Background and Aims

Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope’s optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR.

Methods

In this randomized, controlled, international, multicenter study (11 centers), patients (aged ≥50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard high-definition colonoscopy. The primary endpoint was the ADR.

Results

One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n = 396; balloon-assisted colonoscopy n = 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P = .0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (P = .0033) flat adenomas (P < .0001) and sessile serrated adenomas/polyps (P = .0026).

Conclusion

Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence. (Clinical trial registration number: NCT01917513.)

中文翻译：

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G-EYE结肠镜检查在提高腺瘤检出率方面优于标准结肠镜检查：一项国际随机对照试验（带视频）

背景和目标

大肠癌（CRC）在很大程度上可以通过常规筛查和监测结肠镜检查来预防；然而，标准结肠镜检查遗漏的由癌前病变引起的间歇性癌症仍然存在。现已发现，腺瘤检出率（ADR）升高与间歇性癌症呈负相关。G-EYE设备包括一个可重复使用的球囊，该球囊集成在标准结肠镜的远侧末端，可平展腹腔褶皱，使结肠镜的光学元件居中，并减少肠蠕动。注入的气球还旨在在停药期间增强结肠的可视化，从而增加ADR。

方法

在这项随机，对照，国际，多中心研究（11个中心）中，将在结肠镜检查中筛查，监测或改变排便习惯的年龄≥50岁的患者（随机）通过在术中使用吹气球囊进行球囊辅助结肠镜检查。停药或标准高清结肠镜检查。主要终点是ADR。

结果

在2014年5月至2016年9月之间，有1000名患者参加了由有经验的内镜医师进行结肠镜检查；最后分析803次（标准结肠镜检查n = 396；球囊辅助结肠镜检查n = 407）。两组的基线参数相似。球囊辅助结肠镜检查提供了48.0％的ADR，而标准结肠镜检查组为37.5％（增加28％；P  = 0.0027）。此外，气囊辅助结肠镜检查显着增加了晚期（P  = .0033）扁平腺瘤（P  <.0001）和无 蒂锯齿状腺瘤/息肉（P = .0026）的检测。

结论

与标准结肠镜检查相比，球囊辅助结肠镜检查产生更高的ADR，并增加了对晚期，扁平和无柄锯齿状腺瘤/息肉的检测。G-EYE设备改进的检测可以通过降低漏检率并因此减少间歇性癌症发生率来影响CRC筛查的质量。（临床试验注册号：NCT01917513。）