Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis,JAMA

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Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis
JAMA ( IF 63.1 ) Pub Date : 2020-01-21 , DOI: 10.1001/jama.2019.20967
Yama Issa ₁ , Marinus A Kempeneers ₁ , Marco J Bruno ₂ , Paul Fockens ₃ , Jan-Werner Poley ₂ , Usama Ahmed Ali ₁ , Thomas L Bollen ₄ , Olivier R Busch ₁ , Cees H Dejong _{5,

6} , Peter van Duijvendijk ₇ , Hendrik M van Dullemen ₈ , Casper H van Eijck ₉ , Harry van Goor ₁₀ , Muhammed Hadithi ₁₁ , Jan-Willem Haveman ₁₂ , Yolande Keulemans ₁₃ , Vincent B Nieuwenhuijs ₁₄ , Alexander C Poen ₁₅ , Erik A Rauws ₃ , Adriaan C Tan ₁₆ , Willem Thijs ₁₇ , Robin Timmer ₁₈ , Ben J Witteman ₁₉ , Marc G Besselink ₁ , Jeanin E van Hooft ₃ , Hjalmar C van Santvoort _{20,

21} , Marcel G Dijkgraaf ₂₂ , Marja A Boermeester ₁ ,

Affiliation

Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, Amsterdam, the Netherlands.
Department of Gastroenterology and Hepatology; Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Department of Radiology, St Antonius Hospital, Nieuwegein, the Netherlands.
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands.
Department of Surgery, Universitätsklinikum Aachen, Aachen, Germany.
Department of Surgery, Gelre Hospital, Apeldoorn, the Netherlands.
Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.
Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, the Netherlands.
Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Department of Gastroenterology and Hepatology, Zuyderland Hospital, Sittard/Heerlen, the Netherlands.
Department of Surgery, Isala Hospital, Zwolle, the Netherlands.
Department of Gastroenterology and Hepatology, Isala Hospital, Zwolle, the Netherlands.
Department of Gastroenterology and Hepatology, Canisius-Wilhemina Hospital, Nijmegen, the Netherlands.
Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, the Netherlands.
Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands.
Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, the Netherlands.
Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.
Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands.
Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam Public Health, Amsterdam UMC, University of Amsterdam, the Netherlands.

Importance For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function. Objective To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes. Design, Setting, and Participants The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018. Interventions There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed. Main Outcomes and Measures The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality. Results Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, -12 points [95% CI, -22 to -2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach. Conclusions and Relevance Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings. Trial Registration ISRCTN Identifier: ISRCTN45877994.

中文翻译：

早期手术与内窥镜优先方法对慢性胰腺炎患者疼痛的影响

重要性对于疼痛性慢性胰腺炎患者，手术治疗应推迟到药物和内窥镜治疗失败后。观察性研究表明，早期手术可以减缓疾病进展，提供更好的疼痛控制和保护胰腺功能。目的确定在临床结果方面，早期手术是否比内窥镜优先方法更有效。设计、设置和参与者 ESCAPE 试验是一项非盲法、多中心、随机临床优势试验，涉及荷兰胰腺炎研究组的 30 家荷兰医院。2011年4月至2016年9月，共88例慢性胰腺炎、主胰管扩张、包括最近才开始使用处方阿片类药物治疗严重疼痛的患者（强阿片类药物≤2 个月或弱阿片类药物≤6 个月）。18 个月的随访期于 2018 年 3 月结束。干预随机分配后 6 周内接受胰腺引流手术的 44 名患者随机分配至早期手术组，44 名患者随机分配至内镜优先入路组接受药物治疗，内窥镜检查，包括碎石（如果需要）和手术（如果需要）。主要结果和测量主要结果是疼痛，根据 Izbicki 疼痛评分进行测量并在 18 个月内进行积分（范围，0-100 [评分增加表示疼痛更严重]）。次要结果是随访结束时疼痛缓解；干预措施、并发症、住院次数；胰腺功能; 生活质量（根据 36 项简表健康调查 [SF-36] 测量）；和死亡率。结果在随机分组的 88 名患者（平均年龄 52 岁；21 名 (24%) 女性）中，85 名 (97%) 完成了试验。在 18 个月的随访期间，早期手术组患者的 Izbicki 疼痛评分低于随机接受内窥镜优先入路组的患者（37 vs 49；组间差异，-12 分 [95% CI，-22 至 -2]；P = .02）。早期手术的 40 名患者中有 23 名 (58%) 在随访结束时完全或部分疼痛缓解，而内窥镜先入路组的 41 名患者中有 16 名 (39%) (P = .10)。早期手术组的干预总数较低（中位数，1 对 3；P < .001）。治疗并发症（27% 对 25%）、死亡率（0% 对 0%）、住院、胰腺功能、早期手术和内窥镜优先方法之间的生活质量和生活质量没有显着差异。结论和相关性在慢性胰腺炎患者中，与内窥镜优先方法相比，早期手术在 18 个月内整合后疼痛评分较低。然而，需要进一步研究来评估差异随时间的持续性并复制研究结果。试用注册 ISRCTN 标识符：ISRCTN45877994。需要进一步研究以评估差异随时间的持续性并复制研究结果。试用注册 ISRCTN 标识符：ISRCTN45877994。需要进一步研究以评估差异随时间的持续性并复制研究结果。试用注册 ISRCTN 标识符：ISRCTN45877994。

更新日期：2020-01-21

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