Endocuff 结肠镜与常规结肠镜检查对腺瘤的检出率：一项多中心随机对照试验。
Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial.
机构信息
Departments of Gastroenterology & Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Departments of Gastroenterology & Hepatology, Slotervaartziekenhuis, Amsterdam, The Netherlands.
出版信息
Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16.
BACKGROUND AND AIMS
Colonoscopy is the current reference standard for the detection of colorectal neoplasia, but nevertheless adenomas remain undetected. The Endocuff, an endoscopic cap with plastic projections, may improve colonic visualisation and adenoma detection. The aim of this study was to compare the mean number of adenomas per patient (MAP) and the adenoma detection rate (ADR) between Endocuff-assisted colonoscopy (EAC) and conventional colonoscopy (CC).
METHODS
We performed a multicentre, randomised controlled trial in five hospitals and included fecal immonochemical test (FIT)-positive screening participants as well as symptomatic patients (>45 years). Consenting patients were randomised 1:1 to EAC or CC. All colonoscopies were performed by experienced colonoscopists (≥500 colonoscopies) who were trained in EAC. All colonoscopy quality indicators were prospectively recorded.
FINDINGS
Of the 1063 included patients (52% male, median age 65 years), 530 were allocated to EAC and 533 to CC. More adenomas were detected with EAC, 722 vs 621, but the gain in MAP was not significant: on average 1.36 per patient in the EAC group versus 1.17 in the CC group (p=0.08). In a per-protocol analysis, the gain was 1.44 vs 1.19 (p=0.02), respectively. In the EAC group, 275 patients (52%) had one or more adenomas detected versus 278 in the CC group (52%; p=0.92). For advanced adenomas these numbers were 109 (21%) vs 117 (22%). The adjusted caecal intubation rate was lower with EAC (94% vs 99%; p<0.001), however when allowing crossover from EAC to CC, they were similar in both groups (98% vs 99%; p value=0.25).
INTERPRETATION
Though more adenomas are detected with EAC, the routine use of Endocuff does not translate in a higher number of patients with one or more adenomas detected. Whether increased detection ultimately results in a lower rate of interval carcinomas is not yet known.
TRIAL REGISTRATION NUMBER
http://www.trialregister.nl Dutch Trial Register: NTR3962.
背景与目的
结肠镜检查是当前检测结直肠肿瘤的参考标准，但仍然存在腺瘤漏检的情况。Endocuff 是一种带有塑料突起的内镜帽，可能会改善结肠可视化和腺瘤检出率。本研究旨在比较 Endocuff 辅助结肠镜检查（EAC）和常规结肠镜检查（CC）的患者平均腺瘤数（MAP）和腺瘤检出率（ADR）。
方法
我们在五家医院进行了一项多中心、随机对照试验，纳入了粪便免疫化学检测（FIT）阳性的筛查参与者和症状性患者（>45 岁）。同意参加的患者按 1:1 随机分配至 EAC 或 CC 组。所有结肠镜检查均由经验丰富的（>500 例结肠镜检查）且接受过 EAC 培训的结肠镜检查医师进行。所有结肠镜检查质量指标均前瞻性记录。
结果
在纳入的 1063 例患者中（52%为男性，中位年龄 65 岁），530 例分配至 EAC 组，533 例分配至 CC 组。EAC 组检出的腺瘤更多，分别为 722 个和 621 个，但 MAP 的增加不显著：EAC 组平均每位患者增加 1.36 个，CC 组增加 1.17 个（p=0.08）。在按方案分析中，分别增加 1.44 个和 1.19 个（p=0.02）。EAC 组中，275 例（52%）患者检出一个或多个腺瘤，CC 组为 278 例（52%）（p=0.92）。对于高级别腺瘤，EAC 组为 109 例（21%），CC 组为 117 例（22%）。EAC 组盲肠插管率较低（94% vs 99%；p<0.001），但允许 EAC 交叉至 CC 时，两组相似（98% vs 99%；p 值=0.25）。
结论
虽然 EAC 检出的腺瘤更多，但常规使用 Endocuff 并不能使更多患者检出一个或多个腺瘤。增加的检出率是否最终导致间期癌的发生率降低尚不清楚。
试验注册号
http://www.trialregister.nl Dutch Trial Register：NTR3962.
Zotero 插件