Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-02-07 Sachin Wani, Samuel Han, Violette Simon, Matthew Hall, Dayna Early, Eva Aagaard, Wasif M. Abidi, Subhas Banerjee, Todd H. Baron, Michael Bartel, Erik Bowman, Brian C. Brauer, Jonathan M. Buscaglia, Linda Carlin, Amitabh Chak, Hemant Chatrath, Abhishek Choudhary, Bradley Confer, Rajesh N. Keswani
Differential risk of disease progression between isolated anastomotic ulcers and mild ileal recurrence after ileocolonic resection in patients with Crohn’s disease Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-02-06 Jacob E. Ollech, Maya Aharoni-Golan, Roni Weisshof, Inessa Normatov, Abby R. Sapp, Aditya Kalakonda, Amanda Israel, Laura Glick, Theodore Karrison, Sushila R. Dalal, Atsushi Sakuraba, Russell D. Cohen, David T. Rubin, Joel Pekow
Background and Aims It is standard of care to perform ileocolonoscopy within a year of ileocolonic resection for Crohn’s disease (CD) and to guide management decisions based on the Rutgeert score (RS). The modified RS subdivides i2 into lesions confined to the anastomosis (i2a) or >5 aphthous lesions in the neoterminal ileum (i2b). There is uncertainty, however, if i2a lesions incur an increased risk of disease recurrence. The primary aim of this study was to compare the rates of endoscopic progression between i2a and i2b when compared with i0-i1. Methods This was a retrospective single-center study including patients with CD who had an ileocolonoscopy ≤12 months after ileocolonic resection with primary anastomosis and who had >1 year of documented clinical follow up after the index endoscopic evaluation. All consecutive eligible patients between 2004 and 2014 were included in the study. Demographic, disease, and treatment data were collected. Patients with i3 or i4 at the index colonoscopy were excluded from further analyses. Outcomes included endoscopic progression and recurrent surgery. For patients with RS i0-i2, endoscopic progression was predefined as progression of the RS in subsequent colonoscopies to i3 or i4. Recurrent surgical interventions were defined as re-resection or stricturoplasty of the previous ileocolonic anastomosis. Results Two hundred seven CD patients (median 36 years old (IQR 26-48)) had an ileocolonoscopy ≤12 months after ileocolonic resection. At index colonoscopy, 95 patients (45.9%) had a RS i0, 31 (14.9%) i1, 40 (19.3%) i2a, 25 (12.1%) i2b, 10 (4.8%) i3, and 6 (2.9%) i4. One hundred ninety-one patients had a RS of i0-i2 and were included in the analyses for recurrent surgery. One hundred forty-nine patients had a second endoscopic evaluation and were included in the analysis for the primary outcome of endoscopic disease progression. Kaplan-Meier analyses were performed and found the hazard ratio (HR) of endoscopic progression to be significantly higher with i2b lesions when compared with i0 or i1 (HR, 6.22; 95% CI, 2.38 - 16.2; p=0.0008). Patients with i2a did not have significantly higher rates of endoscopic progression when compared with i0 or i1 (HR, 2.30; 95% CI, 0.80 - 6.66; p=0.12). Likewise, patients with i2b lesions had higher risk of needing recurrent surgery when compared with i0 or i1 (HR, 3.64; 95% CI, 1.10 - 12.1; p=0.034), whereas patients with i2a lesions were not found to have a significantly elevated risk of recurrent surgery (HR, 1.43; 95% CI, 0.35 - 5.77; p=0.62). Conclusions Endoscopic lesions limited to the ileocolonic anastomosis (RS i2a) in patients with Crohn’s disease undergoing colonoscopy within one year of their resection were not associated with a significantly higher rate of progression to more severe disease, whereas those in the neo-ileum (RS i2b) were. Prospective studies are needed to confirm these findings.
The pocket-creation method facilitates colonic endoscopic submucosal dissection (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-02-01 Takahito Takezawa, Yoshikazu Hayashi, Satoshi Shinozaki, Yuichi Sagara, Masahiro Okada, Yasutoshi Kobayashi, Hirotsugu Sakamoto, Yoshimasa Miura, Keijiro Sunada, Alan Kawarai Lefor, Hironori Yamamoto
Background and Aims Colonic endoscopic submucosal dissection (ESD) is more difficult than rectal ESD because of poor maneuverability of the endoscope due to physiological flexion, peristalsis and respiratory movements. The aim of this study is to assess the usefulness of the pocket-creation method (PCM) for colonic ESD compared with the conventional method (CM) regardless of lesion shape or location. Methods A total of 887 colorectal lesions were treated by ESD. Of 887 lesions, 271 rectal lesions, 72 lesions smaller than 20 mm in diameter and one non-neoplastic lesion were excluded. This is a retrospective chart review of the remaining 543 colon lesions in 512 patients. We divided them into the PCM group (n=280) and the CM group (n=263). The primary outcome was the en bloc resection rate. Secondary outcomes included (1) R0 resection (en bloc resection with negative margin), (2) adverse events, (3) dissection time (min), and (4) dissection speed (mm2/min). Results The PCM group achieved a significantly higher en bloc resection rate (PCM: 100%, 280/280 vs CM: 96%, 253/263, p<0.001) and R0 resection rate (91%, 255/280 vs 85%, 224/263, p=0.033) than the CM group. Dissection time was similar (69.5±44.4 vs 78.7±62.6 min, p=0.676). Dissection speed was significantly faster with PCM than CM (23.5±11.6 vs 20.9±13.6 mm2/min, p<0.001). The incidence of adverse events was similar (perforation 2% vs 4%, p=0.152 and delayed bleeding 2% vs 1%, p=0.361). Conclusions Colonic ESD using PCM significantly improves the rates of en bloc resection and R0 resection and facilitates rapid dissection.
Endoscopic stricturotomy versus ileocolonic resection in the treatment of ileocolonic anastomotic strictures in Crohn’s disease Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-30 Nan Lan, Luca Stocchi, Conor P. Delaney, Tracy L. Hull, Bo Shen
Background and Aims Endoscopic stricturotomy is a novel technique in the treatment of anastomotic strictures in Crohn’s disease (CD). The aim of this study was to compare the outcome of patients with ileocolonic anastomotic stricture treated with endoscopic stricturotomy (ESt) versus ileocolonic resection (ICR). Methods This historical cohort study included consecutive CD patients with ileocolonic anastomotic stricture treated with ESt or ICR from 2010 to 2017. The primary outcomes were surgery-free survival and postprocedural adverse events. Results A total of 35 patients treated with ESt and 147 patients treated with ICR were analyzed. The median follow-ups were 0.8 years (interquartile range [IQR]: 0.2-1.7) and 2.2 years (IQR: 1.2-4.4) in the ESt and ICR groups, respectively (<0.001). Subsequent stricture-related surgery was needed in 4 (11.3%) patients receiving ESt and 15 (10.0%) patients receiving ICR (P=0. 89). Kaplan-Meier analysis also showed no statistical difference regarding surgery-free survival between the 2 groups (P=0.24). Procedure-related major adverse events were documented in 5 of 49 (10.2% per procedure) patients undergoing ESt and 46 (32.0%) patients undergoing ICR (P=0.003). Risk factors for decreased surgery-free survival on multivariate analysis included pre-procedural corticosteroids (hazard ratio [HR], 2.8; 95% confidence interval [CI], 1.0-8.1), multiple strictures (HR, 4.9; 95% CI, 1.7-14.2) and increased disease-related hospitalizations (HR, 4.0; 95% CI, 1.2-13.0). Conclusions With the limitation of a shorter follow-up, endoscopic stricturotomy achieved comparable surgery-free survival with a decreased morbidity when compared with ICR.
Yield of repeat colonoscopy in asymptomatic individuals with a positive fecal immunochemical test and recent colonoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-23 Nam Hee Kim, Yoon Suk Jung, Jae Wan Lim, Jung Ho Park, Dong Il Park, Chong Il Sohn
Background and Aims A fecal immunochemical test (FIT) is often repeated annually, even after a recent colonoscopy. However, there are no published data on the proper approach to FIT-positive patients after a recent colonoscopy. We compared colorectal cancer (CRC) and advanced colorectal neoplasia (ACRN) prevalence based on the interval since the last colonoscopy. Methods We reviewed asymptomatic screenees aged ≥50 years who underwent FIT and colonoscopy. Results Of 2,228 FIT-positive participants, the number who had a colonoscopy less than 3 years prior (Group 1), 3 to 10 years prior (Group 2), and >10 years prior or no colonoscopy (Group 3) was 514, 427, and 1,287, respectively. The prevalence of CRC in Groups 1, 2, and 3 was 2.1%, 1.6%, and 7.2%, respectively, and that for ACRN was 10.9%, 12.6%, and 26.0%, respectively. Even after adjusting for confounders, CRC and ACRN detection rates in Group 1 were lower than those in Group 3, but not lower than those in Group 2. Among 6,135 FIT-negative participants, the prevalence of CRC in the 3 groups was 0.7%, 0.4%, and 3.4%, respectively, and that for ACRN was 6.0%, 6.1%, and 14.7%, respectively. CRC and ACRN detection rates were significantly higher in FIT-positive participants than in FIT-negative participants in all 3 groups. Conclusions In FIT-positive patients who underwent colonoscopy within the prior 3 years, CRC and ACRN prevalence was not low. Our findings support the U.S. Multi-Society Task Force on CRC Screening recommendation that repeat colonoscopy be offered to patients with positive FIT results and recent colonoscopy.
Jumbo biopsy forceps versus cold snares for removing diminutive colorectal polyps: A prospective randomized controlled trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-23 Cheal Wung Huh, Joon Sung Kim, Hyun Ho Choi, I So Maeng, Sun-Young Jun, Byung-Wook Kim
Background and Aims Cold snare polypectomy (CSP) and jumbo forceps polypectomy (JFP) have been shown to be effective for removing diminutive colorectal polyps (DCPs) (≤5 mm). However, no study has compared complete resection rates between CSP and JFP for DCPs. The aim of this study was to compare the efficacy and safety of JFP to CSP for the removal of DCPs. Methods This was a prospective randomized controlled trial from 2 tertiary-care referral centers. A total of 1003 patients were screened, and 169 patients with 196 DCPs were enrolled. The main outcome was complete polyp resection rate. Results Of 196 diminutive polyps, 177 (90.3%) were adenomatous polyps. The overall complete resection rate was 92.1% (163/177). The complete resection rate was not significantly different between JFP and CSP groups (92.0% vs 92.2%; P = .947). JFP achieved complete resection rates comparable with CSP for polyps >3 mm (90.3% vs 89.8%; P = .928). Polypectomy procedure time, tissue retrieval rate, and rate of postpolypectomy adverse events was not significantly different between the 2 groups. Conclusions Both JFP and CSP achieved complete resection rates of >90 % for DCPs. Thus, JFP may be considered for polypectomy of DCPs.
A phase 3, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an anti-reflux valve (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-23 Kulwinder S. Dua, John M. DeWitt, William R. Kessler, David L. Diehl, Peter V. Draganov, Mihir S. Wagh, Michel Kahaleh, Louis M. Wong Kee Song, Harshit S. Khara, Abdul H. Khan, Murad M. Aburajab, Darren Ballard, Chris E. Forsmark, Steven A. Edmundowicz, Brian C. Brauer, Amy Tyberg, Najtej S. Buttar, Douglas G. Adler
Background and Aims Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid anti-reflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. Methods A phase 3, multicenter, prospective, noninferiority, randomized, controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Post-deployment dysphagia score at 2 weeks and GERD-HRQL questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. Results 60 patients were randomized (SEMS-NV: N 30, age 67±13SD years; SEMS-V: N 30, age 65±12). Baseline dysphagia scores (SEMS-NV: 2.5±0.8; SEMS-V: 2.5±0.8) and GERD-HRQL scores (SEMS-NV: 11.1 ± 8.2; SEMS-V: 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. Similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia [(SEMS-NV: 71%; SEMS-V 74%; 95% CI, 1.93 (-17.8, 21.7)]. The dysphagia scores were also similar across all follow-up time-points. Mean GERD-HRQL scores improved by 7.4±10.2 points in the SEMS-V arm and by 5.2±8.3 in the SEMS-NV group (p = 0.96). The GERD-HRQL scores were similar across all follow-up time-points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (p = 0.61). Migration rates were similar (SEMS-NV: 33%; SEMS-V: 48%; p=0.29). Two SEMS-V stent spontaneously fractured. There was no perforation, food impaction or stent-related death in either group. Conclusion The SEMS-V stent was equally effective in relieving dysphagia as compared with SEMS-NV stent. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents implying either, that the valve was not effective, or that all patients being on PPIs could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended.
Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center, randomized controlled trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-18 Shengbing Zhao, Xia Yang, Qianqian Meng, Shuling Wang, Jun Fang, Wei Qian, Tian Xia, Peng Pan, Zhijie Wang, Lun Gu, Xin Chang, Duowu Zou, Zhaoshen Li, Yu Bai
The endoscopists’ biopsy rate as a quality indicator for outpatient gastroscopy: a multicenter cohort study with validation Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-17 Wladyslaw Januszewicz, Paulina Wieszczy, Andrzej Bialek, Katarzyna Karpinska, Jakub Szlak, Jakub Szymonik, Maciej Rupinski, Andrzej Mroz, Jaroslaw Regula, Michal F. Kaminski
Background and Aims The gastric premalignant conditions (GPCs) diagnosis rely on endoscopy with mucosal sampling. We hypothesized that the endoscopists’ biopsy rate (EBR) might constitute a quality indicator for esophagogastroduodenoscopy (EGD) and we have analyzed its association with GPC detection and the rate of missed gastric cancers (GCs). Methods We analyzed EGD databases from 2 high-volume outpatient units. EBR values, defined as proportion of EGDs with ≥1 biopsy to all examinations, were calculated for each endoscopist in Unit A (derivation cohort) and divided by the quartile values into 4 groups. GPC detection was calculated for each group and compared using multivariate clustered logistic regression models. Unit B database was used for validation. All patients were followed with Cancer Registry for missed GCs, diagnosed between 1 month and 3 years after negative EGDs. Results Sixteen endoscopists in Unit A performed 17,490 EGDs of which 15,340 (87.7%) were analyzed. EBR quartile values were 22.4% to 36.7% (low EBR), 36.8% to 43.7% (moderate), 43.8% to 51.6% (high), and 51.7% and 65.8% (very-high); median value 43.8%. The moderate, high, and very high EBR groups’ odds ratios of detecting GPC were 1.6 (95% CI, 1.3-1.9), 2.0 (95% CI, 1.7-2.4) and 2.5 (95% CI, 2.1-2.9), respectively, when compared with low EBR group (P<.001). This association was confirmed with the same thresholds in validation cohort. Endoscopists with higher EBR (≥43.8%) had a lower risk of missed cancer as compared with lower EBR group (OR=0.44; 95% CI, 0.20-1.00; P=.049). Conclusions The EBR parameter is highly variable among endoscopists, associated with efficacy in GPC detection and the rate of missed GCs.
variability in cecal intubation rate by calculation method: a call for standardization of key performance indicators in endoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-17 Keith Siau, James Hodson, Srivathsan Ravindran, Matthew D. Rutter, Marietta Iacucci, Paul Dunckley
Background and Aims The cecal intubation rate (CIR) is a widely accepted key performance indicator (KPI) in colonoscopy but lacks a universal calculation method. We aimed to assess whether differences in CIR calculation methods could impact on perceived trainee outcomes. Methods A systematic review of CIR calculation methods was conducted on major societal guidelines (United Kingdom, European Society of Gastrointestinal Endoscopy [ESGE] and American Society for Gastrointestinal Endoscopy [ASGE]) and trainee-inclusive studies. Trainees awarded colonoscopy certification between June 2011 and 2016 were identified from the United Kingdom e-portfolio and selected as a validation cohort. For each trainee, both the crude and unassisted CIR were calculated over 50 post-certification procedures using definitions from the 3 international guidelines. The resulting CIRs, and the proportions of endoscopists failing to meet the minimum standard of CIR ≥90%, were then compared across these definitions. Results Across the 3 guidelines and 37 eligible studies identified, differences in CIR calculation methodology were demonstrated. These related to adjustment criteria (18 studies), and whether unassisted CIR was stipulated (18 studies). In the validation cohort of 733 trainees (36,650 procedures), the median crude CIR ranged from 96% (ESGE) to 98% (ASGE) [p<0.001], and whether unassisted CIR was specified (ESGE: 94%, ASGE: 96%, P<0.001). The proportion of trainees failing to achieve CIR ≥90% varied significantly across the different definitions, from 4.9% in the crude ASGE definition, to 18.6% in the unassisted ESGE definition (p<0.001). Conclusions CIR calculation methods vary between guidelines and research studies, which impact on trainee performance measures. With CIR used as an example, this study highlights the need for standardized definitions and calculations of KPIs in endoscopy.
Prospective assessment of the effectiveness of standard high-level disinfection for echoendoscopes Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-14 Aymeric Becq, Graham M. Snyder, Riley Heroux, Sharon B. Wright, Shishira Bharadwaj, Jonah Cohen, Moamen Gabr, Tyler M. Berzin, Douglas K. Pleskow, Mandeep S. Sawhney
Background and Aims Duodenoscopes have been implicated in the transmission of multidrug-resistant organisms (MDROs). Echoendoscopes could also potentially transmit infection. The aim of this study was to assess the effectiveness of standard high-level disinfection (sHLD) for radial and linear echoendoscopes and to compare it with that of duodenoscopes. Methods We performed a prospective single-center study sampling echoendoscopes immediately before use, from the working channel (radial and linear echoendoscope) and the transducer (radial echoendoscope) or elevator mechanism and transducer (linear echoendoscope). The primary outcome was the proportion of echoendoscopes with any culture showing ≥1 MDRO; secondary outcomes included bacterial growth >0 colony forming units (CFU), and≥10 CFU on either sampling location. We compared these findings with duodenoscope cultures from the previously published DISINFECTS trial. Results During the study period, 101 echoendoscopes were sampled (n=50 radial echoendoscope, n=51 linear echoendoscope). No MDROs were recovered. Bacterial growth >0 CFU was noted in 6% and ≥10 CFU in 3% of all echoendoscopes. There was no significant difference in growth between radial and linear echoendoscopes (p=0.4 for >0 CFU growth; p=0.6 for ≥10 CFU growth). The proportion of transducer/elevator mechanism positive for bacterial growth was significantly higher in duodenoscopes as compared with echoendoscopes (p=0.02). Conclusions After sHLD, no echoendoscope showed MDRO growth, 6% showed >0CFU and 3% showed ≥10CFU bacterial growth. Bacterial growth was higher in duodenoscopes at the level of the transducer/elevator mechanism when compared with echoendoscopes.
Endoscopic full-thickness resection for early colorectal cancer Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-14 Armin Kuellmer, Julius Mueller, Karel Caca, Patrick Aepli, Dani Dakkak, Brigitte Schumacher, Anne Glitsch, Claus Schäfer, Ingo Wallstabe, Christopher Hofmann, Andreas Erhardt, Benjamin Meier, Dominik Bettinger, Robert Thimme, Arthur Schmidt
Background & Aims Current international guidelines recommend endoscopic resection for T1 colorectal cancer (CRC) with histological low-risk features and oncologic resection for those at high-risk of lymphatic metastasis. Exact risk stratification is therefore crucial to avoid under- as well as over-treatment. Endoscopic full-thickness resection (EFTR) has shown to be effective for treatment of nonlifting benign lesions. In this multicenter, retrospective study we aimed to evaluate efficacy, safety and clinical value of EFTR for early colorectal cancer. Methods Records of 1234 patients undergoing EFTR for various indications at 96 centers were screened for eligibility. 156 patients with histological evidence of adenocarcinoma were identified. This cohort comprised 64 cases undergoing EFTR after incomplete resection of a malignant polyp (Group 1) and 92 nonlifting lesions (Group 2). Endpoints of the study were: technical success, R0-resection, adverse events and successful discrimination of high-risk versus low-risk tumors. Results Technical success was achieved in 144 out of 156 (92.3%). Mean procedural time was 42 minutes. R0 resection was achieved in 112 of 156 (71.8%). Subgroup analysis showed a R0 resection rate of 87.5% in Group 1 and 60.9% in Group 2 (p<0.001). Severe procedure-related adverse events were recorded in 3.9% of patients. Discrimination between high-risk versus low-risk tumor was successful in 155 of 156 cases (99.3 %). 84.1% of Group 1 were identified as low-risk lesions, whereas 16.3% in group 2 had low-risk features. In total, 53 patients (34%) underwent oncologic resection due to high-risk features whereas 98 patients (62%) were followed endoscopically. Conclusions In early colorectal cancer, EFTR is technically feasible and safe. It allows exact histological risk stratification and can avoid surgery for low-risk lesions. Prospective studies are required to further define indications for EFTR in malignant colorectal lesions and to evaluate long-term outcome.
Association between duration or etiology of gastroparesis and clinical response after gastric per-oral endoscopic pyloromyotomy Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-14 Parit Mekaroonkamol, Vaishali Patel, Rushikesh Shah, Baiwen Li, Hui Luo, Shanshan Shen, Huimin Chen, Nikrad Shahnavaz, Sunil Dacha, Steven Keilin, Field F. Willingham, Jennifer Christie, Qiang Cai
Background and Aims Gastric per-oral endoscopic pyloromyotomy (GPOEM) is a novel procedure with promising potential for the treatment of gastroparesis but with limited data regarding predictors of clinical response. This study aims to evaluate the safety and efficacy of the procedure and explore the impact of duration and etiology (diabetic vs nondiabetic) of gastroparesis on clinical outcome as measured by the Gastroparesis Cardinal Symptom Index (GCSI). Methods A single-center retrospective longitudinal study at a tertiary care hospital was performed over an 18-month period. A total of 40 patients with refractory gastroparesis (25 nondiabetic and 15 diabetic patients) were included. Results GCSI significantly improved throughout the study period (F (2.176, 17.405)=10.152, p=0.001). The nausea/vomiting subscale showed sustained improvement through 18 months (F (2.213, 17.704)=15.863, p=<0.00001). There was no significant improvement in bloating (F (2.099, 16.791)=1.576, p=0.236). Gastric scintigraphy retention was significantly reduced by 41.7% (t=-7.90; p<0.00001). Multivariate linear regression modeling revealed a significant correlation between the duration of disease and a GCSI improvement at 12 months (p=0.02), with a longer duration of disease being associated with a poorer long-term response. The etiology of gastroparesis was not associated with clinical improvement (p=0.16). Adverse events (7.5%) included one capnoperitoneum, one peri-procedure COPD exacerbation, and one mucosotomy closure site disruption. Conclusion GPOEM appears to be a safe and effective minimally invasive therapy for refractory gastroparesis, especially for patients with predominant nausea/vomiting and shorter duration of disease, regardless of the etiology. We propose the clinical criteria for undergoing GPOEM should be a GSCI of at least 2.0 and a gastric retention of greater than 20%.
The optimal age for screening colonoscopy: a modeling study Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-09 Chen Chen, Christian Stock, Michael Hoffmeister, Hermann Brenner
Background and Aims Recent guidelines on colorectal cancer (CRC) screening recommend starting screening earlier than before. We performed a simulation study to examine and compare the optimal ages to have once-only screening colonoscopy and repeated colonoscopies. Methods A Markov model was set up using data from the German national screening colonoscopy registry to simulate the natural history of the adenoma-carcinoma process. CRC deaths and years of potential life lost (YPLL) for a hypothetical unscreened 50-year-old German population were estimated when they have a single screening colonoscopy or 2 or 3 screening colonoscopies with 10-year intervals at various ages. Results One single screening colonoscopy performed between 50 to 65 years was expected to reduce CRC death by 49% to 69% and YPLL by 51% to 68%. An inverted U-shaped association was found between screening age and proportion of CRC death/YPLL prevented. The optimal age for once-only colonoscopy that yielded the highest reductions in YPLL was around 54 years for males and 56 years for females. Estimates were approximately 6 to 8 years higher when proportions of CRC deaths prevented were examined. For 2 or 3 screening colonoscopies, the optimal starting age fell to around 50 years or even younger for both genders. Conclusions Based on the YPLL estimates, in a high CRC incidence and high life expectancy country like Germany, the optimal age for once-only screening colonoscopy would be around 55 years and possibly slightly younger for men than for women. When 2 or more screening colonoscopies are offered with 10-year intervals, screening should start at age 50 at the latest or possibly even younger for both genders.
Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-09 Viveksandeep Thoguluva Chandrasekar, Marco Spadaccini, Muhammad Aziz, Roberta Maselli, Seemeen Hassan, Lorenzo Fuccio, Abhiram Duvvuri, Leonardo Frazzoni, Madhav Desai, Alessandro Fugazza, Ramprasad Jegadeesan, Matteo Colombo, Chandrashekhar Dasari, Cesare Hassan, Prateek Sharma, Alessandro Repici
Background and Aims Hot snare polypectomy and endoscopic mucosal resection (EMR) are the standard of care in resecting colorectal polyps ≥10 mm. To avoid the risk of electrocautery-induced damage, there is recent evidence about using cold snare polypectomy and cold EMR for such lesions. The aim of this pooled analysis is to report outcomes of cold snare resection (CSR) for polyps ≥10 mm. Methods PubMed/MEDLINE, Embase, Google Scholar and Cochrane databases were searched up to July 2018 to identify studies that performed CSR for colorectal polyps ≥10 mm. The primary outcomes were adverse events (bleeding, perforation, and postpolypectomy abdominal pain). The secondary outcomes were the rates of complete resection, overall residual polyp rates and rates for adenomas versus sessile serrated polyps (SSPs). Sub-group analysis was performed focusing on lesion size, location and resection technique. Results Eight studies were included in the final analysis; 522 CR polyps with a mean polyp size of 17.5 mm (range 10–60 mm). The overall adverse event rate was 1.1% (95% CI, 0.2%–2.0%; I2=0%). Intra- and postprocedural bleeding rates were 0.7% (0%-1.4%) and 0.5% (0.1%-1.2%) respectively, with abdominal pain rate being 0.6% (0.1%-1.3%). Polyps ≥20 mm had higher intra-procedural bleeding rate of 1.3% (0.7%-3.3%) and abdominal pain rate of 1.2% (0.7%-3.0%), but no delayed bleedings. No perforations were reported. The complete resection rate was 99.3% (98.6%-100%). Overall pooled residual rates of polyps of any histology, adenomas and SSPs were 4.1% (0.2%-8.4%), 11.1% (4.1%-18.1%), and 1.0% (95% CI, 0.4%-2.4%), respectively, during a follow-up period ranging from 154 to 258 days. Conclusions The results of this systematic review and pooled analysis show excellent results with cold snare resection of colorectal polyps>10mm in terms of post polypectomy bleeding, complete resection and residual polyp rates. Randomized controlled trials comparing with hot snare resections of polyps ≥10 mm are required for further investigation.
Endoscopic full-thickness muscle biopsy for rectal tissue sampling in patients with severe gut motility disorders: an initial experience (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2019-01-09 Saowanee Ngamruengphong, Elizabeth Thompson, Megan McKnight, Juliana Yang, Pankaj J. Pasricha
Background and Aims Diagnosis of gastrointestinal neuromuscular diseases is mostly on basis of symptomatology and is often unreliable. Pathological analysis of affected tissue eg, the myenteric plexus and muscle, is a potentially valuable method for both diagnosis and advancement of our knowledge about the biological basis for these syndromes. However, until now access to the deeper layers of the GI tract has been limited, generally requiring invasive surgical techniques. Methods We report a “close-then-resect” endoscopic full-thickness biopsy (EFTB) technique using over-the-scope clip and telescope for rectal muscle biopsy in patients with suspected severe neuromuscular gut disorders. The main outcome measures were technical success and adverse events. Results Thirteen patients (11 females; mean age 27 ± 5.4 years) with diffusely delayed colonic transit underwent EFTB. The mean (± SD) procedure time was 30 ± 5.2 minutes. The mean size of resected specimen was 18 ± 3.5 mm. Histological full-thickness tissue samples were achieved for all patients. Postprocedural adverse events were reported in 2 patients and both were graded as mild (one self-limited bleeding and one with rectal pain). Hematoxylin and eosin staining of tissue samples confirmed adequate cross-sectional imaging of muscularis propria in all patients with excellent demonstration of the myenteric plexus and both layers of muscle. Two patients demonstrated a decrease in interstitial cells of Cajal as demonstrated by CD117 staining. No cases demonstrated appreciable inflammation involving myenteric ganglia. Conclusions Diagnostic EFTB with modified over-the-scope clip for close-then-resect method appears to be a safe and effective technique to obtain adequate full-thickness rectal specimens, allowing for both quantitative and qualitative analysis for the diagnosis of neuromuscular GI dysmotility.; Acroymns: EFTB: endoscopic full thickness muscle biopsy; ICCs: Interstitial cells of Cajal; FTRD: full-thickness resection device; OTSC: over-the-scope clip; H&E: Hematoxylin and eosin
Endoscopic and Histologic Features Associated with Gastric Cancer in familial adenomatous polyposis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-28 Pamela J. Leone, Gautam Mankaney, Shashank Sarvapelli, Suha Abushamma, Rocio Lopez, Michael Cruise, Lisa LaGuardia, Margaret O’Malley, James M. Church, Matthew F. Kalady, Carol A. Burke
Background and Aims Gastric cancer (GC) is a newly described cancer risk in Western patients with familial adenomatous polyposis (FAP). Little is known about clinical, endoscopic and pathologic features associated with FAP-related GC. We compared these features in FAP patients with and without GC. Methods FAP patients were identified through the David G. Jagelman Inherited Colorectal Cancer Registries Cologene database. FAP patients with GC and randomly selected FAP patients without GC with >2 EGDs were analyzed. Demographic, clinical, endoscopic and pathologic features were compared. Results Ten FAP patients with GC were identified and 40 age-matched FAP controls were selected. No demographic differences were noted between cases and controls. All GC cases arose in the proximal stomach among gastric polyposis with only 2 being endoscopically visible. The prevalence of gastric polyposis was similar (100% vs 93%). Endoscopic features associated with GC included a carpeting of gastric polyps (100% vs 22.5%), solitary polyps >20 mm (100% vs 0%), and a polypoid mound of polyps (80% vs 0%), all p < 0.001. GC patients had a higher prevalence of gastric adenomas (30% vs 5%, p = 0.048) and polyps with high-grade dysplasia including fundic gland polyps (50% vs 10%, p= 0.01) and pyloric gland adenomas (20% vs 0%, p = 0.037). Conclusions We identified endoscopic features and advanced pathology present in the stomachs of Western patients with FAP who developed GC. UGI surveillance in FAP should include the stomach and awareness of features associated with GC. Optimal approaches to treatment of gastric polyposis and methods of identification of early GC precursors in FAP are needed.
Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-19 Aayed Alqahtani, Abdullah Al-Darwish, Ahmed Elsayed Mahmoud, Yara A. Alqahtani, Mohamed Elahmedi
Background and Aims Questions related to the safety and long-term efficacy of endoscopic sleeve gastroplasty (ESG) are not yet answered. In this paper, we report weight loss, morbidity, revisions, and co-morbidity resolution during the first 18 months after primary ESG. Design This is a consecutive case series from a prospective observational study executed in a specialized center with a standardized pathway for multimodal management of obesity. Results The 1000 patients in this study had a baseline body mass index and age of 33.3 ± 4.5 kg/m2 and 34.4 ± 9.5 years, respectively. Eight hundred ninety-seven (89.7%) were females. Mean % total weight loss (n; N; follow-up rate) at 6, 12, and 18 months was 13.7 ± 6.8% (n=369; N=423; 87.2%), 15.0 ± 7.7% (n=216; N=232; 93.1%), and 14.8 ± 8.5 (n=54; N=63; 85.7%), respectively. Lost to follow-up at the 12- and 18-month visits were 6.9% and 14.3%, respectively. Thirteen of 17 cases of diabetes, all 28 cases of hypertension, and 18 of 32 cases of dyslipidemia were in complete remission by the third month. With regard to postoperative complaints, 924 patients (92.4%) complained of nausea or abdominal pain that were controlled with medications during the first week after ESG. Twenty-four patients were readmitted: severe abdominal pain (n=8), of whom 3 had ESG reversal; postprocedure bleeding (n=7), 2 of whom received 2 units of packed red blood cells each; perigastric collection with pleural effusion (n=4), 3 of whom underwent percutaneous drainage; postprocedure fever with no sequelae (n=5). Eight patients were revised to sleeve gastrectomy, and 5 had redo ESG. No patient required an emergency intervention, and there were no mortalities. Conclusion ESG appears to be well-tolerated, safe, and effective. Significant weight loss occurs during the first 18 months without mortality or significant morbidity. A minority of patients require revision or reversal during the first year.
Comparison of Clinical Prediction Tools and Identification of Risk Factors for Adverse Outcomes in Acute Lower GI Bleeding Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-18 Natalie Tapaskar, Blake Jones, Steve Mei, Neil Sengupta
Background Limited data exist on prediction of adverse outcomes in patients with acute lower gastrointestinal bleeding (LGIB). The purpose of our study was to compare the ability of existing validated clinical risk scores to predict relevant outcomes in LGIB. Methods We performed a prospective observational study of patients admitted with LGIB who underwent colonoscopy at a single center between April 2016 and September 2017. Seven risk scores were calculated at admission (Strate, NOBLADS, Sengupta, Oakland, Blatchford, AIMS65, and Charlson Comorbidity Index). The risk of severe LGIB was determined via univariable and multivariable logistic regression. Area under the receiver operating characteristic curve (AUC) analysis was used to compare the scores. Results We included 170 patients admitted with LGIB requiring colonoscopy. Fifty-two percent (n=89) fit criteria for severe bleeding. Patients with severe bleeding had lower admission hemoglobins (8.6 g/dL vs 11.1 g/dL; p=0.0001), were more likely to have blood transfusions (85% vs 36%; p<0.0001), ICU stays (49% vs 19%; p<0.0001), and longer length of stay (6 days vs 4 days; p=.0009). The Oakland score was best for prediction of severe bleeding (AUC 0.74), Blatchford score for blood transfusion (AUC 0.87), and Strate score for in-hospital recurrent bleeding (AUC 0.66) and endoscopic intervention (AUC 0.62). The strongest individual predictors of severe bleeding were low admission hemoglobin (OR 1.28 per 1g/dL decrease; p=0.0015; 95% CI, 1.10-1.49) and low albumin (OR 2.56 per 1g/dL decrease; p=0.02; 95% CI, 1.16-5.56). Conclusion Admission albumin and hemoglobin were the strongest predictors of severe bleeding. No singular clinical risk tool had the best predictive ability across all outcomes.
Long-term outcomes of endoscopic resection and metachronous cancer after endoscopic resection for adenocarcinoma of the esophagogastric junction in Japan Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-18 Seiichiro Abe, Ryu Ishihara, Hiroaki Takahashi, Hiroyuki Ono, Junko Fujisaki, Akira Matsui, Akiko Takahashi, Kenichi Goda, Kenro Kawada, Tomoyuki Koike, Manabu Takeuchi, Yosuke Tsuji, Dai Hirasawa, Tsuneo Oyama
Background and Aims Endoscopic resection (ER) of superficial adenocarcinoma of the esophagogastric junction (AEJG) has been shown to be safe and effective. However, long-term data in patients undergoing ER for superficial AEGJ in Japan is still limited. The aim of this study was to determine the effect of ER on survival and occurrence of metachronous cancer of patients with superficial EA. Methods A retrospective analysis of patients who underwent endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for superficial EA in 13 centers in Japan was performed. The patients were classified in either low risk or high risk for lymph node metastasis based on histological features. The incidence of metachronous EA as well as, overall survival (OS) and disease-specific survival (DSS) rate were calculated. Results A total of 372 patients who underwent ER were included. A total of 277 patients were low risk and 95 were high risk for lymph node metastasis. Five-year cumulative incidences of local recurrence were 13% and 0.5% in the EMR and ESD group, respectively (p<0.01). A total of 6 deaths were observed in the high-risk group and none in the low-risk group. The 5-year OS rates in the low-risk group, the high-risk group with additional treatment, and the high-risk group without additional treatment were 93.9%, 77.7%, and 81.6%, respectively. The 5-year DSS rates in the three groups were 100%, 94.4%, and 92.8%, respectively. The 5-year cumulative incidence of metachronous EA in 316 patients without additional treatment was 1.1%. Conclusions Favorable long-term outcomes with ER were observed in patients with AEGJ who met the low-risk criteria for lymph node metastasis. ESD was reasonable and effective treatment in Japanese patients.
Safety of endoscopy in cancer patients with thrombocytopenia and neutropenia Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-11 Hamzah Abu-Sbeih, Faisal Shaukat Ali, Emmanuel Coronel, Hsiang-Chun Chen, Xuemei Wang, Phillip Lum, Gladis Shuttlesworth, Manoop S. Bhutani, Gottumukkala S. Raju, Jeffrey H. Lee, John Stroehlein, William A. Ross, Yinghong Wang
Background and Aims Cancer patients are prone to thrombocytopenia and neutropenia, which increase the risk of bleeding and infection. We assessed the safety of endoscopic procedures in cancer patients with thrombocytopenia and/or neutropenia. Methods We studied consecutive cancer patients with thrombocytopenia and/or neutropenia who underwent endoscopic procedures from 2010 through 2015. Neutropenia was defined as an absolute neutrophil count <1000 cells/ μL. Thrombocytopenia was defined as a platelet count <100 × 103/μL. Univariate and multivariate generalized estimating equation models were used to assess factors associated with risk of adverse events or death. Results We identified 588 patients who underwent 783 procedures; 608 procedures were performed in the setting of thrombocytopenia, and 675 procedures in the setting of neutropenia. Concurrent neutropenia and thrombocytopenia were recorded in 500 endoscopies. Twenty-four patients (4.1%) experienced infectious adverse events, whereas, 29 (4.9%) experienced bleeding adverse events within 1 week of the procedure. On multivariate analysis, platelet count ≤50 × 103/μL was associated with risk of bleeding adverse events. In contrast, poor performance status was associated with increased risk of infection adverse events (P < .01). No association was observed between low absolute neutrophil count and infectious adverse events. Poor performance status (P < .01) and platelet count ≤ 100 × 103/μL (P < .05) were associated with increased risk of 30-day mortality. A persistent platelet count <20 × 103/μL after the procedure, with a baseline platelet count of ≤20 × 103/μL before the procedure, was associated with significant risk of bleeding adverse events compared with a platelet count >20 × 103/μL after the procedure (P < .01); furthermore, if the platelet count increased to >50 × 103/μL after the procedure, the bleeding risk after the procedure was greatly reduced (P < .01). Conclusions Endoscopic procedures are relatively safe in cancer patients with platelet count >50 × 103/μL. Nevertheless, a platelet count of ≥20 × 103/μL could be an appropriate threshold for platelet transfusion if 50 × 103/μL is difficult to achieve. The functional status of the patient, in the absence of the need for urgent or necessary endoscopic interventions, should be considered when deciding whether to perform endoscopy. The risk of procedure and the absolute neutrophil count did not seem to affect the outcomes.
Persistent intestinal metaplasia after endoscopic eradication therapy of neoplastic Barrett’s esophagus increases the risk of dysplasia recurrence: meta-analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-07 Tarek Sawas, Mouaz Alsawas, Fateh Bazerbachi, Prasad G. Iyer, Kenneth K. Wang, M. Hassan Murad, David A. Katzka
Background and Aims Endoscopic eradication therapy (EET) is the main treatment for dysplastic Barrett’s esophagus and intramucosal adenocarcinoma. Although the goal of EET is to achieve complete remission of intestinal metaplasia (CRIM), treatment might achieve complete remission of dysplasia (CR-D) only, without achieving CRIM. Persistent intestinal metaplasia after eradication of dysplasia might carry a higher risk for progression into advanced neoplasia. Methods We performed a systematic review and meta-analysis after searching multiple databases to identify studies, which evaluated dysplasia recurrence risk after successful eradication of neoplasia with EET. We calculated pooled cumulative incidence of dysplasia and advanced neoplasia recurrence after CRIM and CR-D only and then compared the 2 using risk ratios. Results Forty studies were included (4410 patients with total follow-up of 12,976 patient-years). A total of 4061 achieved CRIM and 349 CR-D only. The cumulative incidence of CR-D only was 14% (95% CI, 10% - 19%). The pooled cumulative incidence of any dysplasia recurrence after achieving CRIM was 5% ( 95% CI, 3%- 7%) and after achieving CR-D only was 12% (95% CI, 4% - 23%). Comparing dysplasia detection after achieving CR-D only to CRIM showed significantly higher risk for detection after CR-D, risk ratio (RR), 2.8 (95% CI, 1.7 – 4.6). The pooled cumulative incidence rate of high-grade dysplasia (HGD)/esophageal adenocarcinoma (EAC) recurrence was 3% (95% CI, 2% - 4%) after achieving CRIM and 6% (95% CI, 0% - 16%) after achieving CR-D only. Comparing HGD/EAC recurrence after achieving CR-D only with CRIM showed significantly higher risk for recurrence after CR-D: RR, 3.6 (95% CI, 1.45 - 9). When excluding patients who underwent ablation for NDBE only, these differences persisted with dysplasia recurrence after achieving CR-D only compared with CRIM showing a significantly higher risk for recurrence after CR-D: RR, 2.9 (95% CI, 1.66 – 5). Conclusions CRIM was associated with lower risk of dysplasia and advanced neoplasia recurrence compared with CR-D only. Achieving CRIM should remain the goal of EET in dysplastic BE.
Efficacy of the cardiac septal occluder in the treatment of post-bariatric surgery leaks and fistulas Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-06 Alberto Baptista, Diogo Turiani Hourneaux De Moura, Pichamol Jirapinyo, Eduardo Guimarães Hourneaux De Moura, Andres Gelrud, Michel Kahaleh, Alberto Salinas, Luis Carlos Sabagh, Andrés O. Jaramillo, Víctor Zambrano Rincones, Raul Doval, Jack William Bandel, Christopher C. Thompson
Introduction Endoscopy has evolved to become first-line therapy for the treatment of post-bariatric leaks; however, many sessions are often required with variable success rates. Due to these limitations, the use of the cardiac septal defect occluder (CSDO) has recently been reported in this population. Methods This is a multicenter retrospective series in patients with post-bariatric surgical leaks who underwent treatment with CSDO placement. Data were collected including type of surgery, previous treatment details, fistula dimensions, success rate, and adverse events. Leaks were grouped according to the International Sleeve Gastrectomy Expert Panel Consensus. Outcomes included technical and clinical success and safety of the CSDO. Additionally, regression was performed to determine predictors of response. Results Forty-three patients with leaks were included (31 sleeve gastrectomy and 12 Roux-en-Y gastric bypass [RYGB]). They were divided into acute (n=3), early (n=5), late (n=23), and chronic (n=12). Forty patients had failed previous endoscopic treatment and 3 patients had CSDO as the primary treatment. Median follow-up was 34 weeks. Technical success was achieved in 100% and clinical success in 39 patients (90.7%). All chronic, late, and early leaks had successful closure, except one undrained late leak. The 5 patients with early leaks had an initial satisfactory response, but within 30 days, drainage recurred. The CSDO were removed and replaced for larger diameter devices leading to permanent defect closure. All 3 patients with acute leaks were not successful. Regression analysis showed that chronicity and previous treatment were associated with fistula closure, additionally, success rates for late/chronic leaks versus acute/early leaks were 97.1% and 62.5%, respectively (p = 0.0023). Conclusion This first observational study found the CSDO to have a high efficacy rate in patients with non-acute leaks, with no adverse events. All cases of early, late and chronic leaks were successful, except for one undrained late leak. However, early leaks required a second placement of a larger CSDO in all cases. These results suggest that the CSDO should be considered for non-acute fistula and that traditional closure methods are likely preferred in the acute and early settings.
Safety and efficacy of hot avulsion as an adjunct to endoscopic mucosal resection (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-05 Vinod Kumar, Heather Broadley, Douglas K. Rex
Background Excision of all visible neoplastic tissue is the goal of endoscopic mucosal resection (EMR) of colorectal laterally spreading tumors (LSTs). Flat and fibrotic tissue can resist snaring. Ablation of visible polyps is associated with high recurrence rates. Avulsion is a technique to continue resection when snaring fails. Methods We retrospectively analyzed colonic EMRs of 564 consecutive referred polyps between 2015 and 2017. Hot avulsion was used when snaring was unsuccessful. Polyps treated with and without avulsion were compared. Results Hot avulsion was used in 20.9% (n=112) of all resected lesions. The recurrence rates on follow up colonoscopy were 17.52% in avulsion group versus 16.02% in the non-avulsion group (p= 0.76). Hot avulsion was associated with a trend toward higher rates of delayed hemorrhage (5.35% vs 2.58%; p=0.15) and post-coagulation syndrome (1.8% vs 0.47%; p=0.15), but polyps treated with any avulsion were larger than those in which no avulsion was used (p=<0.001). There were an insufficient number of adverse events to perform a multivariable analysis testing the effects of avulsion, size, and location on the risk of overall adverse events. Conclusion Unlike previous reports of using argon plasma coagulation to treat visible polyp during EMR, hot avulsion of visible/fibrotic neoplasia was associated with similar EMR efficacy compared with cases that did not require hot avulsion. The safety profile of hot avulsion appears acceptable.
A risk-scoring model for the prediction of delayed bleeding after colorectal endoscopic submucosal dissection Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-12-03 Myeongsook Seo, Eun Mi Song, Jin Woong Cho, Young Jae Lee, Bo-In Lee, Jin Su Kim, Seong Woo Jeon, Hyun Joo Jang, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon
Background and Aims Delayed bleeding is an important adverse event after colorectal endoscopic submucosal dissection (ESD). We aimed to investigate the incidence and risk factors of delayed bleeding after colorectal ESD, and to develop a risk scoring model for predicting delayed bleeding. Methods This retrospective multicenter study was performed at 5 centers. The derivation and validation cohorts comprised 1189 patients from 1 center and 415 patients from the other 4 centers. We investigated the incidence and risk factors of delayed bleeding. Then, we developed a risk scoring model for predicting delayed bleeding using the data of the derivation cohort. We validated the scoring system in the validation cohort. Results Delayed bleeding occurred in 34 (2.9%) patients in the derivation cohort. In multivariate analysis, the risk factors of delayed bleeding were tumor location in the rectosigmoid colon (odds ratio [OR], 6.49; 95% confidence interval [CI], 1.96-21.42; P=0.002), large tumor (≥30 mm; OR, 2.10; 95% CI, 1.01-4.40; P=0.048), and use of antiplatelet agents except for aspirin alone (OR, 4.04; 95% CI, 1.44-11.30; P=0.008). These 3 factors were incorporated into a risk scoring model for prediction of delayed bleeding. As the score based on this system increased, the incidence of delayed bleeding increased in the validation cohort. Conclusions The risk scoring model incorporating tumor location, tumor size, and use of antiplatelet agents can quantitatively predict the risk of delayed bleeding after colorectal ESD.
A systematic description of the post-EMR defect to identify risk factors for clinically significant post-EMR bleeding in the colon Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-29 Lobke Desomer, David J. Tate, Farzan F. Bahin, Brian Chiang, Halim Awadie, Bronte Holt, Karen Byth, Michael J. Bourke
Introduction and Aims: Clinically significant bleeding (CSPEB) is the most frequent serious adverse event after endoscopic mucosal resection (EMR) of large laterally spreading colonic lesions (LSLs). There is no proven prophylactic therapy, and it remains a significant drawback of EMR. We aimed to systematically describe and evaluate the features of the post-EMR mucosal defect (PED) and their relationship to CSPEB. Methods A prospective study of LSLs referred for EMR at a tertiary centre was performed. PEDs without visible features were recorded as bland blue (BB). Non-bland blue (NBB) PED features included size, number and herniation of submucosal vessels and presence of submucosal haemorrhage, fibrosis, fat, and exposed muscle. NBB PEDs were analyzed for association with CSPEB, defined as bleeding occurring after completion of the procedure necessitating re-admission or re-intervention. Results From April 2012 to May 2017, 501 lesions in 501 patients were eligible for analysis. The frequency of CSPEB was 30 of 501 (6.0%). More than or equal to 3 visible vessels was a significant predictor of CSPEB (P = .016). None of the following showed a significant correlation with CSPEB: presence of visible vessels, their diameter, herniation, nor other nonvascular PED features. Submucosal vessels were more common in the left colon segment (88.6% vs 78.3%, P = .004), and were significantly larger (20.8% vs 12.1% ≥1 mm, P = .037), more numerous (median 4 (IQR 2-7) vs 2 (IQR 1-4), P < .001) vessels, P < .001) and more often herniated (32% vs 22.2%, P = .022). Conclusion More than or equal to 3 visible vessels within the post-EMR defect may be predictive for CSPEB and may define a target group for real-time prophylactic intervention. No other endoscopically visible features of the PEDs were predictive of CSPEB. NCT03117400
Endoscopic intervention and cholecystectomy in pregnant women with acute biliary pancreatitis decreases early readmissions Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-30 Anjuli K. Luthra, Kishan Patel, Feng Li, Jeffrey R. Groce, Luis Lara, Sebastian Strobel, Amy Hosmer, Alice Hinton, Darwin L. Conwell, Somashekar G. Krishna
Background and Aims Acute biliary pancreatitis (ABP) is associated with increased rates of morbidity in pregnancy. Because there is a paucity of population-based studies evaluating ABP in pregnancy, we sought to investigate clinical outcomes in hospitalized pregnant women on a national level. Methods Using the Nationwide Readmission Database (2011-2014), we identified all women (age ≥18 years) with an index admission for ABP in the United States. Multivariate and propensity-score matched analyses were performed to evaluate the impact of pregnancy on the clinical outcomes of early readmission and severe acute pancreatitis (SAP) in ABP. Results There were 7,787 hospitalizations for ABP in pregnant women during the study period. The rate of 30-day readmission was 16.26%; 57% of these early readmissions were due to adverse events of ABP. Compared with nonpregnant women with ABP, ERCP (21.1% vs 25.2%, p<0.001) and cholecystectomy (52.8% vs 55.2%, p = 0.02) were less frequently performed during pregnancy. Propensity-score matched analysis revealed an increased risk of 30-day readmissions in pregnancy (OR, 1.96; 95% CI, 1.67 -2.30) whereas there was no difference in the risk of SAP (OR, 1.09; 95% CI, 0.76 - 1.57). Multivariate analysis demonstrated that weekend admission (OR, 1.40; 95% CI, 1.10 -1.79) and >1 week of hospitalization (OR, 1.75; 95% CI, 1.24 - 2.48) increased the risk of 30-day readmission, whereas ERCP (OR, 0.40; 95% CI, 0.27 - 0.57) and cholecystectomy (OR, 0.13; 95% CI, 0.10-0.18) reduced the odds of early readmission in pregnancy. Conclusions Pregnant women with ABP less frequently undergo timely endoscopic biliary decompression and cholecystectomy. These modifiable factors can potentially lower early readmissions in pregnant women.
Different risk factors between early and late cancer recurrences in patients without additional surgery after noncurative endoscopic submucosal dissection for early gastric cancer Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-19 Shinya Yamada, Waku Hatta, Tooru Shimosegawa, Kohei Takizawa, Tsuneo Oyama, Noboru Kawata, Akiko Takahashi, Shiro Oka, Shu Hoteya, Masahiro Nakagawa, Masaaki Hirano, Mitsuru Esaki, Mitsuru Matsuda, Naoki Nakaya, Takuji Gotoda
Background and Aims Cancer recurrence is observed in some patients without additional radical surgery after endoscopic submucosal dissection (ESD) that does not fulfill the curability criteria for early gastric cancer (EGC), categorized as “noncurative resection” or “curability C-2” in the guidelines. However, time to cancer recurrence is different in such patients. Thus, we aimed to identify the risk factors of early and late cancer recurrences in these patients. Methods Between 2000 and 2011, this multicenter study analyzed 905 patients who were followed up without additional radical surgery after ESD for EGC categorized as curability C-2. We evaluated the risk factors for early and late cancer recurrences, separately, after ESD. Their cut-off value was defined at 2 years. Results Time to cancer recurrence in the enrolled patients showed a bimodal pattern, and the 5-year cancer recurrence rate was 3.2%. Multivariate Cox analyses revealed that lymphatic invasion (hazard ratio [HR], 8.56; P = 0.003) was the sole independent risk factor for early cancer recurrence. Regarding late cancer recurrence, vascular invasion (HR, 4.50; P = 0.039) was an independent risk factor, and lymphatic invasion tended to be a risk factor (HR, 3.63; P = 0.069). Conclusions This multicenter study with the largest cohort demonstrated that lymphatic invasion is mainly associated with early cancer recurrence; however, vascular invasion was a risk only for late recurrence in patients without additional treatment after ESD for EGC categorized as curability C-2. This finding may contribute to the decision making for treatment strategies after ESD, especially in patients with a relatively short life expectancy.
Preoperative Predictors of Choledocholithiasis in Patients Presenting with Acute Calculous Cholecystitis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-19 Phillip R. Chisholm, Arpan H. Patel, Ryan J. Law, Allison R. Schulman, Arti O. Bedi, Richard S. Kwon, Erik J. Wamsteker, Michelle A. Anderson, Grace H. Elta, Shail M. Govani, Anoop Prabhu
Background and Aims Markedly elevated liver chemistries in patients presenting with acute calculous cholecystitis (AC) often prompt an evaluation for concomitant choledocholithiasis (CDL). However, current guidelines directing the workup for CDL fail to address this unique population. The aims of this study are to define the range of presenting lab values and imaging findings in AC, develop a model to predict the presence of concurrent CDL, and develop a management algorithm that can be easily applied on presentation. Methods We conducted a retrospective review of patients presenting with AC to a large tertiary hospital over a 3.5-year period. CDL was defined as common bile duct (CBD) stone(s), sludge, or debris seen on any of the following studies: US, CT, MRI/MRCP, EUS, ERCP, or intraoperative cholangiogram. A multivariable model to predict CDL was developed on 70% of the patients and validated on the remaining 30%. Results 366 patients were identified, with 65 (17.8%) having concurrent CDL. Univariable analysis was used to predict CDL and demonstrated statistically significant odds ratios for transaminases >3-times upper limit of normal, alkaline phosphatase (AlkPhos) above normal, lipase >3-times upper limit of normal, total bilirubin >1.8 mg/dL, and CBD diameter >6 mm. In the validation cohort, an optimal model containing ALT >3-times upper limit of normal, abnormal AlkPhos and CBD diameter >6 mm was found to have an AUROC of 0.91. When 0 or 1 risk factors were present, 98.6% of patients did not have CDL. When all 3 risk factors were present, 77.8% were found to have CDL. Conclusions Patients with AC have a high prevalence of choledocholithiasis. When a validated model is used, application of cutoffs for ALT, AlkPhos, and CBD diameter can effectively triage low and high likelihood patients for CDL to surgery or ERCP, respectively.
Endoscopic control of polyp burden and expansion of surveillance intervals in serrated polyposis syndrome Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-19 Margaret E. MacPhail, Scott B. Thygesen, Nedhi Patel, Heather M. Broadley, Douglas K. Rex
Introduction Serrated polyposis syndrome (SPS) increases colorectal cancer (CRC) risk. We describe the numbers of colonoscopies and polypectomies performed to achieve and maintain low polyp burdens, and the feasibility of expanding surveillance intervals in patients who achieve endoscopic control. Methods We retrospectively evaluated a prospectively collected database on 115 SPS patients undergoing surveillance at Indiana University Hospital between June 2005 and May 2018. The endoscopist provided surveillance interval recommendations based on polyp burden. Endoscopic control was considered successful if surveillance examinations exhibited fewer polyps and if no or only an occasional polyp ≥1 cm in size was present at follow-up. Initial control was designated the clearing phase and the maintenance phase was surveillance after control was established. Results In total, 87 patients (75.7%) achieved endoscopic control, with some others in the clearing phase at this writing. Achieving control required a mean of 2.84 colonoscopies (including the baseline) over 20.4 months and a mean total 27.9 polyp resections. After establishing control, 71 patients were recommended to receive ≥24-month follow-up. Of those, 60 patients (69.0% of patients with initial control) continued surveillance at our center. The mean interval between colonoscopies during maintenance was 19.3 months with 6.74 mean polypectomies per procedure on polyps primarily <1 cm. There were no incident cancers or colon surgeries during maintenance. Conclusion Most patients achieved control of polyp burden with 2 to 3 colonoscopies over 1 to 2 years. After reaching control, 60 patients returned at intervals up to 24 months with no incident cancers and no surgeries required. Expansion of surveillance intervals to 24 months is effective and safe for many SPS patients who reach control of polyp burden.
Adenoma detection rates in colonoscopies for positive fecal immunochemical tests versus direct screening colonoscopies Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-16 John C.T. Wong, Han-Mo Chiu, Hyun-Soo Kim, Jeong-Sik Byeon, Takahisa Matsuda, Nozomu Kobayashi, Deng-Chyang Wu, David E. Ong, Joseph J.Y. Sung,
Background and aim Recent guidelines propose higher adenoma detection rate (ADR) benchmarks for colonoscopies performed for positive fecal immunochemical tests (FIT), but this is based on low quality evidence. We aimed to compare ADR, advanced ADR (AADR), and number of adenoma per colonoscopy (APC) in direct screening colonoscopy (DSC) versus FIT positive colonoscopy (FITC) in a multicenter Asia Pacific cohort to justify differential targets. Methods Asymptomatic average-risk subjects at or above 50 years of age who underwent screening colonoscopy directly or as follow-up for positive OC-Sensor FIT were identified from eight sites across the Asia Pacific region. Overall, sex-specific ADR, overall AADR, and overall APC were compared between the 2 screening methods. Multivariable logistic regression was performed to adjust for confounding by differences in patient characteristics. Linear regression was used to correlate ADR with APC, and to propose APC benchmarks. Results A total of 2,901 (mean age 60.1years, 57% men) individuals had DSC, whereas 2,485 (mean age 62.8 years, 57% men) subjects underwent FITC. Overall ADR (53.6% vs 37.5%; OR, 1.93; p<0.001), male-specific ADR (61.6% vs 44.6%; OR, 2; p<0.001), female-specific ADR (43.2% vs 28.2%; OR, 1.94; p<0.001) and overall advanced ADR (29.9% vs 4.9%; OR, 8.2; p<0.001) in FITC were significantly higher than the corresponding values for DSC. Differences remained significant after adjustment for patient characteristics. ADR was strongly and positively correlated to APC, with an ADR of 45% and 35% correlating to an APC of ∼1 and ∼0.65. Conclusions Results from this international multicenter cohort study provide early evidence that newly proposed higher ADR targets are justified as quality indicators for FIT-positive colonoscopy.
Efficacy of autofluorescence imaging for flat neoplasm detection: a multicenter randomized controlled trial (A-FLAT trial) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-16 Yoji Takeuchi, Manabu Sawaya, Shiro Oka, Naoto Tamai, Takuji Kawamura, Toshio Uraoka, Hiroaki Ikematsu, Tomohiko Moriyama, Masamichi Arao, Hideki Ishikawa, Yuri Ito, Takahisa Matsuda
Background & Aims Colorectal flat (nonpolypoid) lesions can be overlooked during colonoscopy. This study evaluated the efficacy of updated autofluorescence imaging (AFI) for detecting colorectal flat neoplasms. Methods This was a prospective, multicenter, randomized controlled trial in 9 Japanese tertiary institutions. Patients undergoing colonoscopy due to positive fecal immunochemical tests (FIT), surveillance after polypectomy, or investigation of minor symptoms were enrolled and randomly assigned to either the white-light imaging (WLI) or the AFI group. Primary outcome measurement was number of flat neoplasms per patient. Results From November 2015 to June 2017, 817 patients were enrolled. After excluding 15 patients, 802 were finally analyzed (404, WLI; 398, AFI). Patients’ background (sex, age, indication of colonoscopy, experience of endoscopists) and quality of colonoscopy (bowel preparation, sedative use, cecal insertion rate, insertion and withdrawal time) were not different between groups. Number of flat neoplasms in each patient (95% confidence interval) was significantly higher in AFI than in the WLI group (0.87 [0.78–0.97] vs 0.53 [0.46–0.61]), whereas overall and polypoid neoplasm detection were not significantly different between the groups (1.33 [1.22–1.45] vs 1.14 [1.03–1.24], 0.46 [0.40–0.53] vs. 0.60 [0.53–0.68]). Flat neoplasms were more frequently detected in the right-sided colon with AFI (0.61 [0.54–0.70] vs 0.30 [0.25–0.36]), but not in the left-sided colon and rectum (0.26 [0.21–0.32] vs 0.23 [0.19–0.28]). Conclusion Updated AFI improves the detection of flat colorectal neoplasms in the right-sided colon compared with WLI (UMIN Clinical Trials Registry number, UMIN000019355).
Application of convolutional neural network in the diagnosis of the invasion depth of gastric cancer based on conventional endoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-16 Yan Zhu, Qiu-Cheng Wang, Mei-Dong Xu, Zhen Zhang, Jing Chen, Yun-Shi Zhong, Yi-Qun Zhang, Wei-Feng Chen, Li-Qing Yao, Ping-Hong Zhou, Quan-Lin Li
Background and Aims According to guidelines, endoscopic resection should only be performed for patients whose early gastric cancer invasion depth is within the mucosa or submucosa of the stomach regardless of lymph node involvement. The accurate prediction of invasion depth based on endoscopic images is crucial for screening patients for endoscopic resection. We constructed a convolutional neural network computer-aided detection (CNN-CAD) system based on endoscopic images to determine invasion depth and screen patients for endoscopic resection. Methods Endoscopic images of gastric cancer tumors were obtained from the Endoscopy Center of Zhongshan Hospital. An artificial intelligence-based CNN-CAD system was developed through transfer learning leveraging a state-of-the-art pretrained CNN architecture, ResNet50. A total of 790 images served as a development dataset, and another 203 images served as a test dataset. We used the CNN-CAD system to determine the invasion depth of gastric cancer and evaluated the system’s classification accuracy by calculating its sensitivity, specificity, and area under the receiver operating characteristic curve. Results The area under the receiver operating characteristic curve for the CNN-CAD system was 0.94 (95% confidence interval (CI), 0.90–0.97). At a threshold value of 0.5, sensitivity was 76.47%, and specificity was 95.56%. Overall accuracy was 89.16%. Positive and negative predictive values were 89.66% and 88.97%, respectively. The CNN-CAD system achieved significantly higher accuracy (by 17.25%; 95% CI, 11.63–22.59) and specificity (by 32.21%; 95% CI, 26.78–37.44) than human endoscopists. Conclusions We constructed a CNN-CAD system to determine the invasion depth of gastric cancer with high accuracy and specificity. This system distinguished early gastric cancer from deeper submucosal invasion and minimized overestimation of invasion depth, which could reduce unnecessary gastrectomy.
Intestinal metaplasia of the gastric cardia: findings in patients with versus without Barrett’s esophagus Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-14 Hassan A. Siddiki, Dora M. Lam-Himlin, Allon Kahn, M. Veronica Bandres, George E. Burdick, Michael D. Crowell, Rahul Pannala, Francisco C. Ramirez, Marcelo F. Vela, David E. Fleischer
Background and Aims There is controversy about finding intestinal metaplasia (IM) of the gastric cardia on biopsy. The most recent American GI society guideline comments that IM cardia is not more common in patients with Barrett’s. It provides limited guidance on whether the cardia should be treated when patients with Barrett’s undergo endoscopic eradication therapy (EET) and whether the cardia should be biopsied after ablation. The aims of our study were to determine the frequency in the proximal stomach of (1) histologic gastric cardia mucosa and (2) IM cardia. A third aim was to explore the frequency of advanced pathology (dysplasia and adenocarcinoma) in the cardia after Barrett’s patients have undergone EET. Methods Consecutive patients undergoing esophagogastroduodenoscopy between January 2008 and December 2014, who had proximal stomach biopsies were included. Patients who had histologically confirmed Barrett’s were compared with those without Barrett’s. Results Four hundred sixty-two patients, 289 with Barrett’s and 173 without Barrett’s, were included. Histologically confirmed cardiac mucosa was found in 81.6% of all patients. This was more frequent in those with versus without Barrett’s (86% vs 75%; OR, 2.06; 95% CI, 1.28-3.32; p=0.003). IM cardia was more common in the Barrett’s group (17% vs 7%; OR, 2.67; 95% CI, 1.38-5.19; p=0.004). Advanced pathology was more likely in the Barrett’s patients who had undergone EET. Conclusions Cardiac mucosa is present in most patients who undergo endoscopy for upper GI symptoms. IM cardia is more common in patients with Barrett’s than those without. Advanced histologic changes of the cardia were seen only in the subgroup of Barrett’s patients who had undergone EET.
Prevalence of Metastasis and Survival of 788 patients with T1 Rectal Carcinoid Tumors Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-14 Saowanee Ngamruengphong, Ayesha Kamal, Venkata Akshintala, Gulara Hajiyeva, Yuri Hanada, Yen-I. Chen, Omid Sanaei, Daniela Fluxa, Yamile Haito Chavez, Vivek Kumbhari, Vikesh Singh, Anne Marie O'Broin-Lennon, Marcia Irene Canto, Mouen A. Khashab
Background & Aims Prevalence of rectal carcinoids is increasing, partly due to increased colorectal cancer screening. Local excision (endoscopic or trans-anal excision) is usually performed for small (<1-2 cm) rectal carcinoids but data on clinical outcomes from large population-based U.S. studies are lacking. The aims of this study were to determine the prevalence of metastasis of resected small rectal carcinoid tumors using a large national cancer database and to evaluate the long-term survival of patients after local resection as compared with radical surgery. Methods The SEER database was used to identify 788 patients with rectal T1 carcinoids <2 cm in size. Prevalence of metastases at initial diagnosis and risk factors for metastases were analyzed. Cancer-specific survival (CSS) was calculated. Results A total of 727 (92.3%) patients had tumors <10 mm in diameter and 61 (7.7%) had tumors 11 to 19 mm. Overall, 12 patients (1.5%) had metastasis at the time of diagnosis with prevalence of 1.1% in lesions ≤10 mm and 6.6% in lesions 11 to 19 mm (p=0.01). Survival of patients with T1 rectal carcinoids without metastasis was significantly better than those with metastasis (5-year CSS of 100% vs 78%, p<0.001). Of 559 patients with T1N0M0 rectal carcinoids <10 mm, 5-year CSS was 100% in both groups who underwent local excision and those who underwent radical surgery. Conclusions Larger T1 rectal carcinoid tumors (11 – 19 mm) have significantly higher risk of LN metastases compared with those ≤10 mm. Survival is worse with metastatic disease. Local therapy is adequate for T1N0M0 rectal carcinoids ≤10 mm in size with excellent long-term outcomes.
The incremental value of DNA analysis in pancreatic cysts stratified by clinical risk factors Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-14 James Farrell, Mohammad Al-Haddad, Sara A. Jackson, Tamas Gonda
Background and Aims We determined the incremental predictive value of pancreatic cyst fluid molecular analysis to assessing malignancy risk over long term follow-up of a well-characterized cohort, given the underlying predictive value of imaging parameters routinely used to triage such patients. Methods Patients who lacked initial cytologic malignancy in cyst fluid and had final pathology or a follow-up period of >2 years were included. Patient outcomes determined the malignancy-free survival of patients with high-risk stigmata (HRS), worrisome features (WFs) and DNA abnormalities. DNA analysis included 3 abnormalities: (1) loss of heterozygosity mutations among a panel of tumor suppressor genes, (2) Kras mutation, (3) and elevated DNA quantity. Results 478 patients were included; 209 had surgical pathology derived outcomes and 269 had clinical follow-up of >2 years. 11% had malignant outcome. 42 patients had HRS, 272 lacked both HRS and WFs, and 164 lacked HRS but had WFs. DNA abnormalities did not statistically change long-term malignancy risk in patients with HRS or in patients lacking both HRS and WFs. Among patients with WFs, the presence of ≥2 DNA abnormalities significantly increased malignancy risk (RR 5.2, P=0.002) and the absence of all DNA abnormalities significantly decreased risk (RR 0.4, P=0.040). Sensitivity analysis confirmed results of survival analysis over differing baseline malignancy probabilities. Conclusion Our study defines the clinical characteristic of patients in which DNA abnormality testing has the greatest impact on patient outcomes. Use of DNA abnormality testing is supported in a carefully selected patient population limited to cysts with worrisome features.
EUS-guided fiducial placement for GI malignancies: a systematic review and meta-analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-13 Emmanuel Coronel, Irina Mihaela Cazacu, Atsushi Sakuraba, Adriana Alexandra Luzuriaga Chavez, Angad Uberoi, Yimin Geng, Yutaka Tomizawa, Adrian Saftoiu, Eun Ji Shin, Cullen M. Taniguchi, Albert C. Koong, Joseph M. Herman, Manoop S. Bhutani
Background and Aims Image-guided radiotherapy (IGRT) allows the delivery of radiation with high precision to a target lesion while minimizing toxicity to surrounding tissues. Endoscopic ultrasound (EUS) provides excellent visualization of GI tumors and consequently is being used for fiducial placement with increased frequency. Our goal was to perform a systematic review and meta-analysis of studies evaluating the technical aspects, safety and efficacy of EUS fiducial placement for IGRT in GI malignancies. Methods A systematic literature search was carried out in the following databases: Medline, Pubmed, Embase, Web of Science and Cochrane Library, using Medical Subject Headings terms combined with text words. A random effects model was used to determine pooled proportions of technical success, migration and adverse events rates. Heterogeneity was assessed using the I2 statistic. Publication bias was visually inspected by using a funnel plot and by the Begg’s and Egger’s tests. Results Nine full articles and 5 abstracts reporting on 1155 patients, 49% from a single study by Dhadham et al, were included in the meta-analysis. Pooled rate of technical success was 98% (95% CI, 96-99). Moderate heterogeneity (I2 = 34.18) was present, which appeared to be due to variable sample sizes. Publication bias was present suggesting that studies with less substantial outcomes may have not been reported (Begg’s test p = 0.87, Egger’s test p<0.01). Pooled rates for fiducial migration and adverse events were 3% (95% CI, 1.0-8.0) and 4% (95% CI, 3-7), respectively. Conclusions Our meta-analysis showed that EUS-guided insertion of gold fiducials for IGRT is technically feasible and safe. Further controlled studies assessing its long-term effectiveness in gastrointestinal malignancies are needed.
Blue-light imaging has an additional value to white-light endoscopy in visualization of early Barrett's neoplasia. an international multicenter cohort study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-09 A.J. de Groof, A. Swager, R.E. Pouw, B.L.A.M. Weusten, E.J. Schoon, R. Bisschops, O. Pech, A. Meining, H. Neuhaus, W.L. Curvers, J.J. Bergman
Background and Aims Endoscopic features of early neoplasia in Barrett's esophagus (BE) are subtle. Blue-light imaging (BLI) may improve visualization of neoplastic lesions. The aim of this study was to evaluate BLI in visualization of Barrett’s neoplasia. Methods Corresponding whit- light endoscopy (WLE) and BLI images of 40 BE lesions were obtained prospectively and assessed by 6 international experts in 3 assessments. Each assessment consisted of overview and magnification images. Assessments were as follows: Assessment 1: WLE only; Assessment 2: BLI only; and Assessment 3: corresponding WLE and BLI images. Outcome parameters were as follows: (1) appreciation of macroscopic appearance and surface relief (VAS-scores); (2) ability to delineate lesions (VAS-scores); (3) preferred technique for delineation (ordinal scores); and (4) quantitative agreement on delineations (AND/OR scores). Results Experts appreciated BLI significantly better than WLE for visualization of macroscopic appearance (median 8.0 vs 7.0, P<0.001) and surface relief (8.0 vs 6.0, P<0.001). For both overview and magnification images, experts appreciated BLI significantly better than WLE for ability to delineate lesions (8.0 vs 6.0, P<0.001 and 8.0 vs 5.0, P<0.001). There was no overall significant difference in AND/OR scores of WLE+BLI when compared with WLE, yet agreement increased significantly with WLE+BLI for cases with a low baseline AND/OR score on WLE, both in overview (mean difference 0.15, P=0.015) and magnification (mean difference 0.10, P=0.01). Conclusions BLI has additional value for visualization of BE neoplasia. Experts appreciated BLI better than WLE for visualization and delineation of BE neoplasia. Quantitative agreement increased significantly when BLI was offered next to WLE for lesions that were hard to delineate with WLE alone.
Efficacy of 3 fine-needle biopsy techniques for suspected pancreatic malignancies in the absence of an on-site cytopathologist Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-04 Ka Young Lee, Hyun Deuk Cho, Young Hwangbo, Jae Kook Yang, Su Jung Han, Hyun Jong Choi, Yun Nah Lee, Sang-Woo Cha, Jong Ho Moon, Young Deok Cho, Sang-Heum Park, Tae Hoon Lee
Background and Aims EUS-guided fine-needle aspiration/biopsy (EUS-FNA/B) has a high diagnostic accuracy for pancreatic tumors. Most reports have focused on the diagnostic yield of cytology or histology; the ability of various FNA/B techniques to obtain an adequate mass of cells or tissue has rarely been investigated. Methods Patients with suspected pancreatic malignancy were sampled by EUS-FNB using a 22-gauge ProCore needle by either the stylet slow-pull-back technique (group A), conventional negative-suction after stylet removal (group B) or non-suction after stylet removal (group C) in the absence of on-site cytopathologist. The adequacy of 3 techniques based on the diagnostic yield, cellularity, blood contamination, and core-tissue acquisition was evaluated. Results A total of 50 patients (27 males) were analyzed. The mean tumor size was 21 to 40 mm in 54%. The rate of a good or excellent proportion of cellularity was highest in group A compared with groups B and C (72% vs 60% vs 50%, p = 0.049). A >25% rate of blood contamination was more prevalent in group B (30% vs 42% vs 10%, p = 0.009). The rate of adequate core-tissue acquisition was not different (52% vs 34% vs 50%, p = 0.140). Based on the multivariate generalized estimation equation, stylet slow-pull-back technique and a tumor size of >40 mm were a favorable factor for diagnostic adequacy. Conclusions The stylet slow-pull-back technique might enable acquisition of tissue and assessment of cellularity for the diagnosis of pancreatic tumors suspected to be malignant.
Application of deep learning to predict advanced neoplasia using big clinical data in colorectal cancer screening of asymptomatic adults Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-04 Hyo-Joon Yang, Chang Woo Cho, Sang Soo Kim, Kwang-Sung Ahn, Soo-Kyung Park, Dong Il Park
Background and Aims We aimed to develop deep learning models for the prediction of the risk of advanced colorectal neoplasia (ACRN) in asymptomatic adults based on which colorectal cancer screening could be customized. Methods We collected data on 26 clinical and laboratory parameters including age, sex, smoking status, body mass index, complete blood count, blood chemistry, and tumor marker from 70,336 first-time screening colonoscopy recipients. For reference, we used a logistic regression (LR) model with nine variables. Two deep neural network (DNN) models were developed: Model 1 used the same nine variables and Model 2 included all 26 variables. The area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were compared for the models in a randomly split test set. Results Compared with the LR model (AUC, 0.721; 95% confidence interval [CI], 0.680–0.762), the DNN Model 1 (AUC, 0.817; 95% CI, 0.789–0.847) and Model 2 (AUC, 0.860; 95% CI, 0.837–0.883) showed significantly improved performance with respect to the prediction of ACRN (both P<.001). For a sensitivity of 80%, the specificity of the LR, and DNN Models 1 and 2 were 50.5%, 65.8%, and 78.8%, respectively (both P vs LR model < .001), indicating that the colonoscopy workload required to detect a similar number of ACRNs could be reduced by 58.4% and 73.7% using the DNNs. Conclusions The application of DNNs to big clinical data could significantly improve the prediction of ACRNs compared with the LR model, implying the potential for realizing further improvements using large quantities and various types of biomedical information.
Efficacy and safety of EUS-guided liver biopsy: a systematic review and meta- analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-31 Babu P. Mohan, Mohammed Shakhatreh, Rajat Garg, Suresh Ponnada, Douglas G. Adler
Risk of bacterial exposure to the endoscopist’s face during endoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-01 Elyse R. Johnston, Nadia Habib-Bein, Jeffrey M. Dueker, Barbara Quiroz, Enrico Corsaro, Megan Ambrogio, Michael Kingsley, Georgios I. Papachristou, Christianna Kreiss, Asif Khalid
Background and Aims Non-universal use of facial protection during endoscopy may place endoscopists at risk of exposure to blood and body fluids; however, the frequency of exposure is unknown. Methods A prospective 6-month study of 4 gastroenterologists using a face shield during endoscopy was undertaken. The face shield was swabbed in a standardized fashion before and at the end of the session. Controls included pre- and post-swabs of face shields placed on the (1) endoscopy suite wall, (2) remote patient intake bay wall, and (3) after deliberate contamination with a colonoscope immediately after colonoscopy. The swabs were cultured for 48 hours and growth reported as no growth or by number of colony-forming units (CFU). The groups were compared for +CFU rate and CFU number. Results A total of 1100 procedures were performed in 239 endoscopy sessions. The +CFU rate in the pre-endoscopy groups (2-4.8% p=NS) was significantly lower than the post-endoscopist face shield (45.8%, p<0.001), and endoscopy suite wall groups (21.4%, p<0.001), respectively. Using a cut-off of >15 CFU as an indicator of definite exposure, the occurrence rate was 5.6 per 100 half days of endoscopy to the endoscopists face and 3.4 per 100 days of endoscopy 6 feet away. Conclusions This is the first study to quantify the rate of unrecognized exposure to the endoscopist’s face to potentially infectious biological samples during endoscopy (5.6/100 days of endoscopy). This exposure may result in transmission of infectious diseases. As such, we recommend the use of universal facial protection during GI endoscopy.
Transvaginal natural orifice transluminal endoscopic surgery in the diagnosis of ascites of unknown origin Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-01 Shu-ling Li, Li Zhao, Zi-kai Wang, Wen Li
Background and Aims Natural orifice transluminal endoscopic surgery (NOTES) has been established in animal models and human studies, but few clinical studies have investigated transvaginal NOTES in the diagnosis of unexplained refractory ascites. We aimed to assess the feasibility, efficacy, and safety of transvaginal NOTES for the diagnosis of unexplained ascites in female patients. Methods A prospective study was done involving 3 female patients with unexplained ascites. After general anesthesia and disinfection, a 1.0-cm incision was made in the posterior fornix of the vagina. A gastroscope was inserted into the abdominal cavity through the transvaginal incision and an artificial pneumoperitoneum was created; NOTES peritoneoscopy was performed to scrutinize the pathologic changes. Endoscopic biopsies were obtained for pathological examination. The transvaginal incision was closed by direct suturing. Results Transvaginal NOTES for diagnostic peritoneoscopy was successfully performed in 3 patients. The mean operative time was 61 minutes. The estimated blood loss was 5 to 10 mL. The pathological diagnoses were tuberculosis for all patients, and the symptoms and ascites disappeared after anti-tuberculosis therapy. During the 4-year follow-up, no clinically significant adverse events occurred in any patient after NOTES. No patient experienced an annex inflammation, vaginitis, dyspareunia, or sexual dysfunction. All patients were comfortable and satisfied with the nonscarring surgical procedure. Conclusion Transvaginal NOTES for the diagnosis of unexplained ascites is feasible, effective and safe. This method had no long-term effect on female sexual function and is particularly suitable for women who have special aesthetic requirements. (Clinical trial registration number: ChiCTR-TRC-10001053.)
Endosheath ultrathin transnasal endoscopy is a cost-effective method for screening for Barrett’s esophagus in patients with GERD symptoms Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-29 Judith Honing, Wietske Kievit, Jan Bookelaar, Yonne Peters, Prasad G. Iyer, Peter D. Siersema
Background and Aims Barrett’s esophagus (BE) screening is currently not considered to be cost effective in the general population but may be effective in high-risk subgroups, such as 50-year-old white men with chronic reflux disease (GERD). A new modality for screening is unsedated transnasal endoscopy using endosheath technology (uTNE), which has been shown to be safe and effective in clinical practice. In this study, we determined the cost-utility of uTNE in a high-risk subgroup compared with no screening or screening with standard endoscopy (SE). Methods A Markov model was used to simulate screening of 50-year-old white men with symptoms of GERD with either uTNE or standard endoscopy compared with no screening, over a lifetime horizon. Input variables were based on the literature and recent data on uTNE screening for BE. The study was designed from a healthcare payer perspective using direct costs. Primary outcome measures were costs, quality-adjusted life-years (QALY) and incremental cost-utility ratio (ICUR) of uTNE and standard endoscopy compared with no screening. Sensitivity analysis was performed for several factors such as prevalence of BE. Results Costs of uTNE, standard endoscopy, and no screening were estimated at, respectively, $2495, $2957, and $1436. Compared with no screening, uTNE screening resulted in an overall QALY increase of 0.039 (95% percentile 0.018; 0.063) and an ICUR of $29,446 per QALY gained (95% CI, 18.516 – 53.091), whereas standard endoscopy compared with no screening resulted in a QALY increase of 0.034 (95% CI, 0.015 - 0.056) and an ICUR of $47,563 (95% CI, 31.0361 – 82.970). Conclusions Both uTNE and standard endoscopy seem cost effective screening methods in a screening cohort of 50-year-old white men with GERD at a willingness to pay cut-off of $50,000.
Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-26 X. Yu, S.N. van Munster, Y. Zhang, L. Xue, D.E. Fleischer, B. Weusten, N. Lu, S.M. Dawsey, J.J.G.H.M. Bergman, G. Wang
Background and aims Radiofrequency ablation (RFA) is accepted treatment for flat Barrett’s neoplasia. Less is known about RFA for esophageal squamous-cell neoplasia (ESCN). Our group has reported several prospective studies of RFA for ESCN in China with promising results through 12 months of follow-up. In this cohort study, we aimed to evaluate longer-term outcomes after RFA for ESCN. Methods Patients with flat unstained lesions (USLs) on Lugol’s endoscopy containing moderate/high-grade intra-epithelial neoplasia (MGIN/HGIN) or mucosal cancer were treated with RFA every 3 months until complete remission (CR; no MGIN+). Patients with CR at 12 months (CR12) were included for follow-up and underwent annual Lugol’s endoscopy with biopsies and re-RFA for flat USLs. The clinical course of patients with persistent ESCN at 12 months (treatment failures) is also reported. Results Among the 78 CR12 patients, 67 (86%) had sustained CR during a median 48 months (IQR 48-48) of follow-up and 5 endoscopies (IQR 4-6). Recurrence occurred in 7 out of 78 patients (9%; MGIN(6), HGIN(1)); all lesions were managed with RFA. Four other patients (5%) had progression (to HGIN(n=1); ESCC-sm(n=3)). During follow-up, protocol violations occurred in 46 of 78 patients (59%). Of the 12 treatment failures, progression occurred in 6. Overall, 2 patients developed subepithelial disease that was not visible after Lugol’s. Based on post-hoc analysis, the pink-color sign at baseline (a pink color change after Lugol’s) significantly predicted failure after RFA. Conclusion RFA is relatively easy to apply and can efficiently treat large areas with ESCN. Despite protocol violations that may have interfered with the efficacy of RFA in 59% of patients, the great majority with CR12 had sustained CR during follolw-up. However, some patients progressed to advanced disease and 2 developed subepithelial disease, not visible after Lugol’s. Based on currently available data, we advise to restrict the use of RFA for flat MGIN and HGIN without the pink-color sign on Lugol’s chromoendoscopy.
Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-26 Lawrence Hookey, Alan Barkun, Richard Sultanian, Robert Bailey
Background and Aims Acute lower GI bleeding is a frequent cause of hospital admission. The objective of this study was to evaluate the safety and performance of a hemostatic powder (TC-325/Hemospray) in the treatment of nonvariceal lower GI bleeding. Methods Patients were enrolled into this prospective, multicenter, single-arm study at 4 tertiary care centers in Canada. Fifty patients with active lower GI bleeding of multiple different etiologies (52 bleeding sites) underwent topical endoscopic application of hemostatic powder. The primary endpoint was powder-related adverse events within 30 days of the index procedure. Secondary endpoints were initial hemostasis as well as recurrent bleeding and mortality within 30 days of the index procedure. Results Most patients (96%) had a single bleeding site and most bleeding (73%) was due to polypectomy. Overall, the powder was applied as monotherapy in 13 bleeding sites (25%), as combination therapy in 22 bleeding sites (42.3%), and as rescue therapy in 17 bleeding sites (32.7%). Hemostasis was achieved in 98% of patients. No patient experienced a powder-related adverse event. Five patients (10%) developed recurrent bleeding within 30 days. One patient (2%) died within 30 days of powder application, but the death was not directly related to hemostatic powder use. Conclusions The hemostatic powder is a safe and effective option for patients with lower gastrointestinal bleeding of varying etiologies, and in particular, postpolypectomy hemorrhage. The hemostatic powder is effective as monotherapy, part of a combination approach, or as a rescue therapeutic option for the treatment of nonvariceal lower GI bleeding.
Automatic detection of erosions and ulcerations in wireless capsule endoscopy images based on a deep convolutional neural network Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-25 Tomonori Aoki, Atsuo Yamada, Kazuharu Aoyama, Hiroaki Saito, Akiyoshi Tsuboi, Ayako Nakada, Ryota Niikura, Mitsuhiro Fujishiro, Shiro Oka, Soichiro Ishihara, Tomoki Matsuda, Shinji Tanaka, Kazuhiko Koike, Tomohiro Tada
Background and Aims Although erosions and ulcerations are the most commonly found small-bowel abnormalities on wireless capsule endoscopy (WCE), a computer-aided detection method has not been established. We aimed to develop an artificial intelligence system with deep learning to automatically detect erosions and ulcerations in WCE images. Methods We trained a deep convolutional neural network (CNN) system based on a Single Shot Multibox Detector, using 5,360 WCE images of erosions and ulcerations. We assessed its performance by calculating the area under the receiver operating characteristic curve (ROC-AUC), and its sensitivity, specificity, and accuracy using an independent test set of 10,440 small-bowel images including 440 images of erosions and ulcerations. Results The trained CNN required 233 seconds to evaluate 10,440 test images. The AUC for the detection of erosions and ulcerations was 0.958 (95% confidence interval [CI], 0.947-0.968). The sensitivity, specificity, and accuracy of the CNN were 88.2% (95% CI, 84.8%-91.0%), 90.9% (95% CI, 90.3%-91.4%), and 90.8% (95% CI, 90.2%-91.3%), respectively, at a cut-off value of 0.481 for the probability score. Conclusions We developed and validated a new system based on CNN to automatically detect erosions and ulcerations in WCE images. This may be the crucial step for the development of a daily-use diagnostic software for WCE images to help reduce oversights and the burden on physicians.
Prediction of individuals at high absolute risk of esophageal squamous cell carcinoma Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-25 Qiao-Li Wang, Jesper Lagergren, Shao-Hua Xie
Background and Aims This study aimed to develop a prediction model for identifying individuals at high absolute risk of esophageal squamous cell carcinoma (ESCC) for endoscopic screening at a curable stage based on readily identifiable risk factors. Methods This was a nationwide Swedish population-based case-control study, including 167 new cases of ESCC and 820 randomly selected control participants. Odds ratios with 95% confidence intervals (CI) were assessed using multivariable unconditional logistic regression. The discriminative accuracy of the model was assessed by the area under the receiver operating characteristic curve (AUC) with leave-one-out cross-validation. Models for projecting individuals’ absolute 5-year risk of ESCC were developed by incorporating the age- and sex-specific incidence rates and competing risk of death from other causes. Results A model including the risk factors age, sex, tobacco smoking, alcohol overconsumption, education, duration of living with a partner, and place of residence during childhood generated an AUC of 0.81 (95% CI, 0.77-0.84). A model based only on age, sex, tobacco smoking, and alcohol overconsumption obtained a similar AUC (0.79; 95% CI, 0.75-0.82). A 5-year follow-up of 761 men aged 70 to 74 years with over 35 years’ smoking and alcohol overconsumption history is needed to detect one ESCC case. The estimated individuals’ absolute 5-year risk of ESCC varied according to combinations of risk factors. Conclusions This “easy-to-use” risk prediction model showed a good discriminative accuracy and had the potential to identify individuals at high absolute risk of ESCC who might benefit from tailored endoscopic screening and surveillance.
Underwater endoscopic mucosal resection for colorectal lesions: a systematic review with meta-analysis (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-25 Marco Spadaccini, Lorenzo Fuccio, Laura Lamonaca, Leonardo Frazzoni, Roberta Maselli, Milena Di Leo, Piera Alessia Galtieri, Vincenzo Craviotto, Ferdinando D’Amico, Cesare Hassan, Alessandro Repici
Background and Aims Underwater endoscopic mucosal resection (UEMR) is an alternative way to have nonpedunculated colorectal (CR) lesions lifted before being resected. The endoscopist takes advantage of the behavior of mucosal lesions floating away from the muscular layer, once immersed in liquid. We performed a systematic review with meta-analysis to evaluate the efficacy and safety of this technique. Methods Electronic databases (Medline, Scopus, EMBASE) were searched up to May 2018. Full articles including patients with CR lesions resected by the UEMR technique were eligible. The complete resection (primary outcome), en-bloc resection, recurrence and adverse event rates were pooled by means of a random- or fixed-effect model. Results Ten studies were eligible providing data on 508 lesions removed in 433 patients (m/f=239/194; means ages range: 62.2-75.0 years). Six studies were performed in United States and the other in Europe; 7 studies were prospective. The specific indications for performing UEMR varied widely across the studies. Complete resection rate was 96.36% (95% CI, 91.77-98.44) with a rate of en-bloc resection of 57.07% (95% CI, 43.20%-69.91%). The recurrence rate was 8.82% (95% CI, 5.78-13.25) in a mean endoscopic surveillance period of 7.7 months (range 4-15). The postprocedural bleeding rate was 2.85% (95% CI, 1.64-4.90). Intraprocedural bleedings were always mild and were considered as part of the procedure in all series. The overall adverse events rate was 3.31% (95% CI, 43.20%-69.91%). No cases of perforation were reported. Conclusion According to the results of this systematic review, UEMR appears to be an effective and extremely safe technique for resecting nonpolypoid colorectal lesions.
Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Joseph C. Anderson, Charles J. Kahi, Andrew Sullivan, Margaret MacPhail, Jonathan Garcia, Douglas K. Rex
Background and Aims Although water exchange may improve adenoma detection when compared to CO2, it is unclear whether water is a better medium to fill the lumen during withdrawal and visualize the mucosa. Total underwater (TUC) involves the use of water exchange with the air valve off during insertion followed by the inspection of the mucosa under water. Our goal was to use a tandem colonoscopy design to compare miss rates for TUC to standard CO2 for polyps and adenomas. Methods We randomized participants (NCT03231917; clinicaltrials.gov) to undergo tandem colonoscopies using TUC or CO2 first. In TUC, water exchange was performed during insertion and withdrawal was performed under water. For the CO2 colonoscopy both insertion and withdrawal were performed with CO2. The main outcomes were miss rates for polyps and adenomas for the first examination calculated as the number of additional polyps/adenomas detected during the second examination divided by the total number of polyps/adenomas detected for both examinations. Inspection times were calculated by subtracting time for polypectomy and care was given to keep the times equal for both examinations. Results A total of 121 participants were randomized with 61 having CO2 first. The overall miss rate for polyps was higher for the TUC first group (81/237; 34%) as compared to the CO2 first cohort (57/264; 22%)(p=0.002). In addition, the overall miss rate for all adenomas was higher for the TUC first group (52/146; 36%) as compared with the CO2 group (37/159; 23%) (p=0.025). However, 1 of the 3 endoscopists had higher polyp/adenoma miss rates for CO2 but these were not statistically significant differences. The insertion time was longer for TUC than CO2. After adjusting for times, participant characteristics and bowel preparation, the miss rate for polyps was higher for TUC than CO2. Conclusions We found that TUC had an overall higher polyp and adenoma miss rate than colonoscopy performed with CO2, and TUC took longer to perform. However, TUC may benefit some endoscopists, an issue that requires further study.
Novel Computer-assisted Diagnosis System for Endoscopic Disease Activity in Patients with Ulcerative Colitis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Tsuyoshi Ozawa, Soichiro Ishihara, Mitsuhiro Fujishiro, Hiroaki Saito, Youichi Kumagai, Satoki Shichijo, Kazuharu Aoyama, Tomohiro Tada
Background and Aims Evaluation of endoscopic disease activity for patients with ulcerative colitis (UC) is important when determining the treatment of choice. However, endoscopists require a certain period of training to evaluate the activity of inflammation properly, and interobserver variability exists. Therefore, we constructed a computer-assisted diagnosis (CAD) system using a convolutional neural network (CNN) and evaluated its performance using a large data set of endoscopic images from patients with UC. Methods A CNN-based CAD system was constructed based on GoogLeNet architecture. The CNN was trained using 26,304 colonoscopy images from a total number of 841 patients with UC, which were tagged with anatomical locations and Mayo endoscopic scores. The performance of the CNN in identifying normal mucosa (Mayo 0) and mucosal healing state (Mayo 0–1) were evaluated in an independent test set of 3,981 images from 114 patients with UC, by calculating the areas under the receiver operating characteristic curves (AUROCs). Additionally, AUROCs in the right side of the colon, left side of the colon, and rectum were evaluated. Results The CNN-based CAD system showed a high level of performance with AUROCs of 0.86 and 0.98 to identify Mayo 0 and 0–1, respectively. The performance of the CNN was better in the rectum than in the right side and left side of the colon when identifying Mayo 0 (AUROC= 0.92, 0.83, and 0.83, respectively). Conclusions The performance of the CNN-based CAD system was robust when used to identify endoscopic inflammation severity in patients with UC, highlighting its promising role in supporting less experienced endoscopists and reducing interobserver variability.
A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Priscilla A. van Riet, Alberto Larghi, Fabia Attili, Guido Rindi, Nam Quoc Nguyen, Andrew Ruszkiewicz, Masayuki Kitano, Takaaki Chikugo, Harry Aslanian, James Farrell, Marie Robert, Adebowale Adeniran, Schalk van der Merwe, Tania Roskams, Kenneth Chang, Fritz Lin, John G. Lee, Paolo Giorgio Arcidiacono, Marco J. Bruno
Background and Aims Several studies have compared EUS fine-needle aspiration (FNA) with biopsy (FNB) needles, but none has proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle. Methods Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). Primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders. Results A total of 608 patients were allocated to FNA (n=306) or FNB (n=302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (p=0.043), without differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histological yield (77% vs 44%, p<0.001), accuracy for malignancy (87% vs 78%, p=0.002) and Bethesda classification (82% vs 72%, p=0.002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (OR, 3.53; 95% CI, 1.55-8.56; p=0.004), and did not differ between centers (p=0.836). Conclusion The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histological yield and diagnostic accuracy. This benefit was irrespective of the indication and consistent among participating centers, supporting the general applicability of our findings.
Role of interventional inflammatory bowel disease in the era of biological therapy: a position statement from the Global Interventional IBD Group Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Bo Shen, Gursimran Kochhar, Udayakumar Navaneethan, Xiuli Liu, Francis A. Farraye, Yago Gonzalez Lama, David Bruining, Darrell S. Pardi, Martin Lukas, Martin Bortlik, Kaicun Wu, Ajit Sood, David A. Schwartz, William J. Sandborn,
Interventional (or therapeutic) inflammatory bowel disease (IBD) endoscopy has an expanding role in the treatment of disease and surgical adverse events. Endoscopic therapy has been explored and used in the management of strictures, fistulas/abscesses, colitis-associated neoplasia, post-surgical acute or chronic leaks, and obstructions. The endoscopic therapeutic modalities include balloon dilation, stricturotomy, stent placement, fistulotomy, fistula injection and clipping, sinusotomy, endoscopic mucosal resection, and endoscopic submucosal dissection. With a better understanding of the disease course of IBD, improved long-term impact of medical therapy, and advances in endoscopic technology, we can foresee interventional IBD becoming an integrated part of the multidisciplinary approach to patients with complex IBD.
Diagnostic Yield and Miss Rate of EndoRings in an Organized Colorectal Cancer Screening Program: the SMART (Study Methodology for ADR-Related Technology) Trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Cesare Hassan, Carlo Senore, Gianpiero Manes, Lorenzo Fuccio, Federico Iacopini, Luigi Ricciardiello, Andrea Anderloni, Leonardo Frazzoni, Riccardo Ballanti, Germana de Nucci, Dora Colussi, Davide Radaelli, Roberto Lorenzetti, Massimo Devani, Ilaria Arena, Cristina Grossi, Fabio Andrei, Eleonora Balestrazzi, Alessandro Repici
Background and aims The add-on EndoRings has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty on their correspondence. Aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods Consecutive subjects undergoing colonoscopy after a positive fecal immunochemical test (FIT) within organized screening program in 7 Italian centers, were randomized between a parallel (EndoRings or Standard) or a crossover (EndoRings/Standard or Standard/EndoRings) methodology. Outcomes measures were the detection rates of (advanced) adenomas (A-)ADR in the parallel arms and miss rate of adenomas in the crossover arms. Results Of 958 eligible subjects, 927 (317 EndoRings; 317 Standard; 142 EndoRings/Standard; 151 Standard/Endorings) were included in the final analysis. In the parallel arms (mean ADR: 51.3%; mean AADR: 25.4%), no difference between Standard and EndoRings was found for both ADR (RR, 1.10; 95% CI, 0.95-1.28) and A-ADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings: 1.9±1.3 and 1.0±1.2; Standard 2.1±1.5 and 1.0±1.2; p=NS for both comparisons). In the crossover arms, no difference in miss rate for adenomas between EndoRings and Standard was found at per-polyp (RR, 1.43; 95% CI, 0.97-2.10), as well as at per-patient analysis (24% vs 26%; p=0.76). Conclusions No statistically significant difference in diagnostic yield and miss rate between EndoRings and Standard colonoscopy was detected in FIT+ patients. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship.; Acronyms: E: Endorings; S: Standard; CRC: colorectal cancer; FIT: faecal immunochemical test; (A-) ADR: (Advanced-) adenoma detection rate; SSP: sessile serrated polyp; DR: detection rate
Comparison of Flexible Endoscopic Cricopharyngeal Myectomy and Myotomy Approaches for Zenker Diverticulum Repair a Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Maoyin Pang, Andree Koop, Bhaumik Brahmbhatt, Michael J. Bartel, Timothy A. Woodward
Background and Aims Incision of the cricopharyngeal (CP) muscle with flexible endoscopy is an important approach for Zenker diverticulum (ZD) repair with symptomatic resolution in approximately 90% of cases, but recurrence has been reported in up to 20%. We report our experience with a new endoscopic myectomy of the CP muscle and compare the outcome with conventional myotomy of ZD. Methods Our retrospective study included all patients with ZD who underwent endoscopic repair between August 1, 2014, and July 31, 2017. Conventional CP myotomy was defined as a vertical cut through the CP muscle. CP myectomy was defined as parallel excisions followed by snare resection at the CP resection base. Measurement of ZD size was based on barium esophagram and endoscopic estimation. Outcomes included ZD recurrence, improvement of dysphagia, and procedure adverse events. Results Sixty-four patients underwent endoscopic repair for ZD, 44 had CP myotomy and 20 had CP myectomy. Mean (SD) size of ZD was 3.3 (1.0) cm and 3.8 (1.2) cm in the myotomy and myectomy cohorts, respectively (P = .11), and median (range) procedure time was 50 and 56 minutes, respectively (P = .73). In the CP myotomy cohort, 10 (22.7%) patients had recurrence of ZD at a median (range) of 19.1 months, whereas no recurrence has been documented in the CP myectomy cohort (P = .02). This trend was also shown in multivariate analysis even though no statistical significance (P = .07). There was no statistical difference in improvement of dysphagia and adverse events. Conclusions CP myectomy is a new endoscopic technique for ZD repair. In our experience, it was safe and well tolerated, with a high initial success rate and less ZD recurrence when compared with myotomy.
The comparison of monopolar hemostatic forceps with soft coagulation versus hemoclip for peptic ulcer bleeding: a randomized trial (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Bilal Toka, Ahmet Tarik Eminler, Cengiz Karacaer, Mustafa Ihsan Uslan, Aydin Seref Koksal, Erkan Parlak
Background and Aims Although various methods are used in the treatment of peptic ulcer bleeding, there is not a standard recommended approach. The choice depends on multiple factors such as location of the ulcer, clinical experience of endoscopist and local facilities of the clinic. We aimed to compare the efficacy of monopolar hemostatic forceps soft coagulation (MHFSC) and hemoclips (HC) in the treatment of peptic ulcer related upper GI bleeding. Patients and Methods The study group included patients who had GI bleeding due to Forrest 1a, 1b, 2a gastric or duodenal ulcers within 1 year. Patients with bleeding diathesis, history of gastrectomy, pregnancy, or <18 years were excluded. The remaining were randomized to MHFSC and HC treatment groups and compared in terms of clinical and endoscopic features, initial hemostasis success rates, recurrent bleeding rates within the first 7 days, time to achieve hemostasis, length of hospitalization stay, and adverse events. Results One hundred twelve patients were randomized to MHFSC (n=56) and HC (n =56) groups. There was no statistically significant difference between the groups with respect to demographic features, medications, underlying chronic diseases, location and Forrest classification of the ulcers. The initial hemostasis success rate was 98.2% (55/56) in the MHFSC group and 80.4% (45/56) in the HC group (p=0.004). Recurrent bleeding was detected in 2 patients in the MHFSC group (3.6%) and 8 patients in the HC group (%17.7%) (p=0.04). The duration of endoscopic procedures (302 ± 87.8 vs 568 ± 140.4 seconds) and the length of hospital stay were significantly shorter (3.50 ± 1,03 vs 4.37 ± 1.86 days) in the MHFSC group. There were no adverse events in both groups. Conclusion MHFSC is more effective in achieving initial hemostasis compared with HC in the treatment of peptic ulcer bleeding and provides a shorter procedure time and a lower recurrent bleeding rate.
Increasing prevalence of high-grade dysplasia and adenocarcinoma on index endoscopy in Barrett’s esophagus over the past 2 decades: data from a multicenter U.S. consortium Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Madhav Desai, David A. Lieberman, Kevin F. Kennedy, Nour Hamade, Prashanthi Thota, Sravanthi Parasa, Venkat Subhash Gorrepati, Ajay Bansal, Neil Gupta, Srinivas Gaddam, Patrick E. Young, Sharad Mathur, Fouad J. Moawad, Brooks D. Cash, Richard Sampliner, John J. Vargo, Gary W. Falk, Prateek Sharma
Introduction Data on time trends of dysplasia and esophageal adenocarcinoma (EAC) in Barrett’s esophagus (BE) during the index endoscopy (ie, prevalent cases) are limited. Our aim was to determine the prevalence patterns of BE associated dysplasia on index endoscopy over the past 25 years. Methods The Barrett’s esophagus study is a multicenter outcome project of a large cohort of BE patients. Proportion of patients with index endoscopy findings of no dysplasia (NDBE), low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC) were extracted per year of index endoscopy, and 5-yearly patient cohorts were tabulated over years 1990 to 2010+ (2010-current). Prevalent dysplasia and endoscopic findings were trended over the past 25 years using percentage dysplasia (LGD, HGD, EAC, and HGD/EAC) to assess changes in detection of BE associated dysplasia over the last 25 years. Statistical analysis was done using software SAS version 9.4 (Cary, NC). Results A total of 3643 patients were included in the analysis with index endoscopy showing: NDBE in 2513 (70.1%), LGD in 412 (11.5%), HGD in 193 (5.4%), and EAC in 181 (5.1%). Over time, there was an increase in the mean age of BE patients (51.7 ± 29 years vs 62.6 ± 11.3 years) and proportion of males (84 % vs 92.6%) diagnosed with BE but a decrease in the mean BE length (4.4±4.3 cm vs 2.9±3.0 cm) as time progressed (1990-1994 to 2010-2016 time periods). Presence of LGD on index endoscopy remained stable over years 1990 to 2016. However, a significant increase (148% in HGD and 112% in EAC) in the diagnosis of HGD, EAC, and HGD/EAC were noted on index endoscopy over last 25 years (p<0.001) . There was also a significant increase in the detection of visible lesions on index endoscopy (1990-1994: 5.1% to 2005-2009: 6.3% and 2010+:16.3%) during the same period. Conclusion Our results suggest that the prevalence of HGD and EAC has significantly increased over the past 25 years despite a decrease in BE length during the same period. This rise parallels an increase in the detection of visible lesions, suggesting that a careful examination at the index examination is crucial.
Automated polyp detection in the colorectum: a prospective study (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Peter Klare, Christoph Sander, Martin Prinzen, Bernhard Haller, Sebastian Nowack, Mohamed Abdelhafez, Alexander Poszler, Hayley Brown, Dirk Wilhelm, Roland M. Schmid, Stefan von Delius, Thomas Wittenberg
Background and Aims Adenoma detection is a highly personalized task that differs markedly between endoscopists. Technical advances are therefore desirable for the improvement of the adenoma detection rate (ADR). An automated computer driven technology would offer the chance to objectively assess the presence of colorectal polyps during colonoscopy. We present here the application of a real-time automatic polyp detection software (APDS) under routine colonoscopy conditions. Methods This was a prospective study at a university hospital in Germany. A prototype of a novel APDS software (“KoloPol,” Fraunhofer IIS Erlangen, Germany) was used for automated image-based polyp detection. The software functions by highlighting structures of possible polyp-lesions in a color-coded manner during real time colonoscopy procedures. Testing the feasibility of APDS deployment under real time conditions was the primary goal of the study. APDS polyp detection rates were defined as secondary endpoints provided that endoscopists’ detection served as criterion standard. Results APDS was applied in 55 routine colonoscopies without the occurrence of any clinically relevant adverse events. Endoscopists’ polyp and adenoma detection rates were 56.4% and 30.9%. APDS polyp and adenoma detection rates were 50.9% and 29.1%. APDS detected 55 out of a total of 73 polyps (75.3%). Smaller polyp size and flat polyp morphology were correlated with insufficient polyp detection by APDS. Conclusion Computer-assisted automated low-delay polyp detection is feasible during real-time colonoscopy. Efforts should be undertaken in order to improve APDS with respect to smaller and flat shaped polyps.
Outcome of endoscopic mucosal resection in Barrett’s esophagus determined by systematic quantification of epithelial glands using volumetric laser endomicroscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-16 Amrit K. Kamboj, Allon Kahn, Tarek Sawas, Lori Lutzke, Prasad G. Iyer, Kenneth K. Wang, Cadman L. Leggett
Background Dysplastic Barrett’s esophagus (BE) lesions ≤2 cm in size can be targeted for en-bloc endoscopic mucosal resection (EMR). White-light endoscopy can underestimate the size of a lesion, limiting complete resection. Volumetric laser endomicroscopy (VLE) provides high-resolution cross-sectional imaging of BE. Epithelial glands are a VLE feature associated with BE dysplasia. We study the association between VLE gland quantification and outcome of resection. Methods Endoscopic mucosal resection (EMR) specimens of BE lesions targeted for en-bloc resection were imaged with VLE using an established protocol. Manual and automated quantification of epithelial glands was performed blinded to resection outcome. The presence of epithelial glands at the resection margins was recorded. Histologic en-bloc (R0) resection of the targeted lesion was defined by the absence and incomplete (R1) resection by the presence of dysplasia/neoplasia at specimen margins. Results Thirty-seven EMRs with a mean (SD) size of 1.04 (0.37) cm were imaged with VLE. The highest grade of dysplasia was low-grade dysplasia (N=12), high-grade dysplasia (N=19), and intramucosal cancer (N=6). The en-bloc resection rate was 37.8% (R0: N=14; R1: N=23). The mean (SD) number of epithelial glands quantified with VLE was 13.0 (6.7) and 28.8 (23.9) for R0 and R1 specimens respectively, with a significant mean difference of 15.8 glands (95% CI, 2–29, p=0.02). The presence of glands at the specimen margin was associated with incomplete resection (p<0.001). Conclusion Systematic quantification of BE epithelial glands using VLE can determine the outcome of endoscopic resection. Volumetric laser endomicroscopy may have a potential role in lesion margin assessment.
Clear liquid diet before bowel preparation predicts successful chromoendoscopy in patients with inflammatory bowel disease Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-16 Bryant Megna, Jennifer Weiss, Dana Ley, Sumona Saha, Patrick Pfau, Ian Grimes, Zhanhai Li, Freddy Caldera
Background and Aims Chromoendoscopy (CE) has been shown to generate both a superior diagnostic yield and dysplasia detection rate than conventional white-light endoscopy and requires a high-quality bowel preparation. The aim of this study was to identify predictors of the ability to perform CE in patients with inflammatory bowel disease (IBD). Methods We performed an observational study of patients with IBD undergoing colorectal cancer surveillance examinations with CE. Same day colonoscopy surveys were used to collect patient and procedural variables. Multivariate logistical regression was used to establish odds ratios (OR) of successful completion of CE. Results Eighty-eight patients with IBD were enrolled. We found that patients that did not follow a clear liquid diet before colonoscopy had much lower odds of being able to undergo CE (OR, 0.106; 95% CI, 0.013-0.845; p<0.034). Further, we found that previously identified risk factors (older age, history of diabetes mellitus, the timing and split-dosing of preparation solution, and procedure time (AM or PM), chronic narcotic use, and history of constipation) for inadequate bowel preparation were not associated with the ability to perform CE. Conclusions Following a clear liquid diet the entire day before procedure was highly predictive of the ability to perform CE. However, established risk factors for inadequate bowel preparation did not inhibit the ability to perform CE in our population. Endoscopists performing CE should consider recommending patients to follow a clear liquid diet the entire day before their examination.
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