Background and Aims

Mucosal exposure devices including distal attachments such as the cuff and cap have shown variable results in improving adenoma detection rate (ADR) compared with high-definition white light colonoscopy (HDWLE).

Methods

We performed a prospective, multicenter randomized controlled trial in patients undergoing screening or surveillance colonoscopy comparing HDWLE to 2 different types of distal attachments: cuff (CF) (Endocuff Vision) or cap (CP) (Reveal). The primary outcome was ADR. Secondary outcomes included adenomas per colonoscopy, advanced adenoma and sessile serrated lesion detection rate, right-sided ADR, withdrawal time, and adverse events. Continuous variables were compared using Student's t test and categorical variables were compared using chi-square or Fisher's exact test using statistical software Stata version16. A P value <.05 was considered significant.

Results

A total of 1203 subjects were randomized to either HDWLE (n = 384; mean 62 years of age; 81.3% males), CF (n = 379; mean 62.7 years of age; 79.9% males) or CP (n = 379; mean age 62.1 years of age; 80.5% males). No significant differences were found among 3 groups for ADR (57.3%, 59.1%, and 55.7%; P = .6), adenomas per colonoscopy (1.4 ± 1.9, 1.6 ± 2.4, and 1.4 ± 2; P = .3), advanced adenoma (7.6%, 9.2%, and 8.2%; P = .7), sessile serrated lesion (6.8%, 6.3%, and 5.5%; P = .8), or right ADR (48.2%, 49.3%, and 46.2%; P = .7). The number of polyps per colonoscopy were significantly higher in the CF group compared with HDWLE and CP group (2.7 ± 3.4, 2.3 ± 2.5, and 2.2 ± 2.3; P = .013). In a multivariable model, after adjusting for age, sex, body mass index, withdrawal time, and Boston Bowel Preparation Scale score, there was no impact of device type on the primary outcome of ADR (P = .77). In screening patients, CF resulted in more neoplasms per colonoscopy (CF: 1.7 ± 2.6, HDWLE: 1.3 ± 1.7, and CP: 1.2 ± 1.8; P = .047) with a shorter withdrawal time.

Conclusions

Results from this multicenter randomized controlled trial do not show any significant benefit of using either distal attachment devices (CF or CP) over HDWLE, at least in high-detector endoscopists. The Endocuff may have an advantage in the screening population. (ClinicalTrials.gov, Number: NCT03952611).

中文翻译：

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高清结肠镜检查与袖带和帽辅助结肠镜检查的比较：来自多中心、前瞻性、随机对照试验的结果

背景和目标

与高清白光结肠镜检查 (HDWLE) 相比，包括袖带和帽子等远端附件在内的粘膜暴露装置在提高腺瘤检出率 (ADR) 方面显示出不同的结果。

方法

我们在接受结肠镜筛查或监测的患者中进行了一项前瞻性、多中心随机对照试验，比较了 HDWLE 与 2 种不同类型的远端附件：袖带 (CF) (Endocuff Vision) 或帽 (CP) (Reveal)。主要结果是 ADR。次要结局包括每次结肠镜检查的腺瘤、晚期腺瘤和无蒂锯齿状病变检出率、右侧 ADR、停药时间和不良事件。使用学生t检验比较连续变量，使用统计软件 Stata 版本 16 使用卡方或 Fisher 精确检验比较分类变量。P值 <.05 被认为是显着的。

结果

共有 1203 名受试者被随机分配到 HDWLE（n = 384；平均 62 岁；81.3% 男性）、CF（n = 379；平均 62.7 岁；79.9% 男性）或 CP（n = 379；平均年龄 62.1 岁；80.5% 为男性）。3 组之间的 ADR（57.3%、59.1% 和 55.7%；P = .6）、每次结肠镜检查的腺瘤（1.4 ± 1.9、1.6 ± 2.4 和 1.4 ± 2；P = .3）、晚期腺瘤（7.6%、9.2% 和 8.2%；P = .7）、无蒂锯齿状病变（6.8%、6.3% 和 5.5%；P = .8）或右侧 ADR（48.2%、49.3% 和46.2%；P = .7)。CF 组每次结肠镜检查的息肉数量显着高于 HDWLE 和 CP 组（2.7 ± 3.4、2.3 ± 2.5 和 2.2 ± 2.3；P =.013)。在一个多变量模型中，在调整了年龄、性别、体重指数、戒断时间和波士顿肠道准备量表评分后，设备类型对 ADR 的主要结果没有影响 ( P = .77)。在筛查患者时，每次结肠镜检查 CF 导致更多的肿瘤（CF：1.7 ± 2.6，HDWLE：1.3 ± 1.7，和 CP：1.2 ± 1.8；P = .047），停药时间更短。

结论

这项多中心随机对照试验的结果未显示使用任何一种远端附件装置（CF 或 CP）优于 HDWLE，至少在高探测器内镜医师中没有任何显着优势。Endocuff 在筛查人群中可能具有优势。（ClinicalTrials.gov，编号：NCT03952611）。