Gastroenterology, Liver and Nutrition Institute, Assaf Harofeh Medical Center, Tzrifin, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Gastroenterology and Liver Institute, Laniado Hospital, Netanya, Israel.
Gastrointest Endosc. 2019 Mar;89(3):545-553. doi: 10.1016/j.gie.2018.09.028. Epub 2018 Sep 28.
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.
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.
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).
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.).
结直肠癌（CRC）通过常规筛查和监测结肠镜检查基本可以预防；然而，标准结肠镜检查遗漏的癌前病变仍会出现间期癌。腺瘤检出率（ADR）的增加与间期癌呈负相关。G-EYE 设备包括一个可重复使用的球囊，集成在标准结肠镜的远端尖端，可使皱襞变平、将结肠镜的光学中心化，并减少肠道滑脱。充气球囊还旨在增强退镜时的结肠可视化，从而提高 ADR。
在这项随机、对照、国际、多中心研究（11 个中心）中，因筛查、监测或肠习惯改变而接受结肠镜检查的患者（年龄≥50 岁）被随机分为两组，一组在退镜时使用充气球囊进行球囊辅助结肠镜检查，另一组进行标准高清结肠镜检查。主要终点是 ADR。
2014 年 5 月至 2016 年 9 月期间，1000 名患者入组接受经验丰富的内镜医生进行结肠镜检查；最终有 803 名患者进行了分析（标准结肠镜组 396 名，球囊辅助结肠镜组 407 名）。两组的基线参数相似。球囊辅助结肠镜检查的 ADR 为 48.0%，标准结肠镜组为 37.5%（增加 28%；P=.0027）。此外，球囊辅助结肠镜检查显著增加了对高级（P=.0033）平坦腺瘤（P <.0001）和无蒂锯齿状腺瘤/息肉（P=.0026）的检出率。
与标准结肠镜检查相比，球囊辅助结肠镜检查可提高 ADR，并增加对高级、平坦和无蒂锯齿状腺瘤/息肉的检出率。G-EYE 设备的检测改善可能通过降低漏诊率从而降低间期癌的发生率来影响 CRC 筛查的质量。（临床试验注册号：NCT01917513.）。
