Department of Clinical Medicine and Surgery, University Federico II of Naples, School of Medicine, Naples, Italy.
Department of Public Health, University Federico II of Naples, School of Medicine, Naples, Italy.
Gastrointest Endosc. 2018 Jan;87(1):232-240. doi: 10.1016/j.gie.2016.12.027. Epub 2017 Jan 9.
EndoCuff is a disposable device applied to standard colonoscopes to improve mucosal visualization. Randomized parallel trials have shown that EndoCuff increases the adenoma detection rate (ADR). The primary aim of this study was to compare the ADR between EndoCuff-assisted colonoscopies (EAC) and standard colonoscopies within a randomized back-to-back trial.
This was a single-center randomized crossover study (NCT02374515) involving adult patients undergoing screening, surveillance, or diagnostic colonoscopy. Participants received back-to-back standard colonoscopies and EACs in a random order, performed by the same endoscopist. All polyps were excised, but only those proven at histology to be adenomas were considered for analysis.
From February 2015 to March 2016, a total of 288 patients were enrolled, and 274 were included in the per-protocol analysis. Compared with standard colonoscopies, EACs increased the ADR (29.6% vs 26.3%; P < .01) and the number of diagnosed adenomas (176 vs 129; P < .01), particularly in the left (73 vs 46; P < .01) and right sides of the colon (83 vs 63; P < .01). EAC increased the detection of adenomas <5 mm (129 vs 84; P < .01), but no difference was found with regard to larger lesions. In 7.3% of patients, findings of EndoCuff shortened the surveillance interval determined by standard colonoscopy findings. EndoCuff caused 7 mucosal erosions (2.5% of patients), requiring a mucosal adrenaline injection in 1 case.
The use of EndoCuff increases the number of identified adenomas, primarily small adenomas in the left and right sides of the colon. This increases the ADR and allows a better definition of the surveillance program. (Clinical trial registration number: NCT02374515.).
EndoCuff 是一种应用于标准结肠镜的一次性设备，可改善黏膜可视化效果。随机平行试验表明，EndoCuff 可提高腺瘤检出率（ADR）。本研究的主要目的是在一项随机背靠背试验中比较 EndoCuff 辅助结肠镜检查（EAC）和标准结肠镜检查的 ADR。
这是一项单中心、随机交叉研究（NCT02374515），纳入接受筛查、监测或诊断性结肠镜检查的成年患者。参与者以随机顺序接受背靠背的标准结肠镜检查和 EAC，由同一位内镜医生进行。所有息肉均被切除，但仅分析经组织学证实为腺瘤的息肉。
2015 年 2 月至 2016 年 3 月，共纳入 288 例患者，274 例患者纳入意向治疗分析。与标准结肠镜检查相比，EAC 增加了 ADR（29.6%比 26.3%；P<0.01）和诊断腺瘤的数量（176 个比 129 个；P<0.01），尤其是在结肠的左侧（73 个比 46 个；P<0.01）和右侧（83 个比 63 个；P<0.01）。EAC 增加了<5mm 腺瘤的检出率（129 个比 84 个；P<0.01），但较大病变的检出率无差异。在 7.3%的患者中，EndoCuff 的检查结果缩短了标准结肠镜检查结果确定的监测间隔。EndoCuff 导致 7 例黏膜糜烂（占患者的 2.5%），其中 1 例需要黏膜肾上腺素注射。
使用 EndoCuff 增加了腺瘤的数量，主要是结肠左侧和右侧的小腺瘤。这提高了 ADR，并能更好地定义监测计划。（临床试验注册号：NCT02374515）。
