Department of Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, UK.
Department of Gastroenterology, North Tees and Hartlepool NHS Foundation Trust, Stockton, UK.
Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.
Low adenoma detection rates (ADR) are linked to increased postcolonoscopy colorectal cancer rates and reduced cancer survival. Devices to enhance mucosal visualisation such as Endocuff Vision (EV) may improve ADR. This multicentre randomised controlled trial compared ADR between EV-assisted colonoscopy (EAC) and standard colonoscopy (SC).
Patients referred because of symptoms, surveillance or following a positive faecal occult blood test (FOBt) as part of the Bowel Cancer Screening Programme were recruited from seven hospitals. ADR, mean adenomas per procedure, size and location of adenomas, sessile serrated polyps, EV removal rate, caecal intubation rate, procedural time, patient experience, effect of EV on workload and adverse events were measured.
1772 patients (57% male, mean age 62 years) were recruited over 16 months with 45% recruited through screening. EAC increased ADR globally from 36.2% to 40.9% (P=0.02). The increase was driven by a 10.8% increase in FOBt-positive screening patients (50.9% SC vs 61.7% EAC, P<0.001). EV patients had higher detection of mean adenomas per procedure, sessile serrated polyps, left-sided, diminutive, small adenomas and cancers (cancer 4.1% vs 2.3%, P=0.02). EV removal rate was 4.1%. Median intubation was a minute quicker with EAC (P=0.001), with no difference in caecal intubation rate or withdrawal time. EAC was well tolerated but caused a minor increase in discomfort on anal intubation in patients undergoing colonoscopy with no or minimal sedation. There were no significant EV adverse events.
EV significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection.
NCT02552017, Results; ISRCTN11821044, Results.
腺瘤检出率 (ADR) 较低与结直肠癌术后结直肠癌症发生率增加和癌症生存率降低有关。增强黏膜可视化的设备，如 Endocuff Vision (EV)，可能会提高 ADR。这项多中心随机对照试验比较了 EV 辅助结肠镜检查 (EAC) 与标准结肠镜检查 (SC) 的 ADR。
因症状、监测或粪便潜血试验 (FOBt) 阳性而接受检查的患者，以及作为结直肠癌筛查计划一部分的患者，从七家医院招募。测量 ADR、平均每例检出的腺瘤数量、腺瘤的大小和位置、无蒂锯齿状息肉、EV 切除率、盲肠插管率、操作时间、患者体验、EV 对工作量的影响和不良事件。
在 16 个月内招募了 1772 名患者（57%为男性，平均年龄 62 岁），其中 45%通过筛查招募。EAC 使全球 ADR 从 36.2%增加到 40.9%（P=0.02）。FOBt 阳性筛查患者的 ADR 增加了 10.8%（50.9% SC 与 61.7% EAC，P<0.001），这一增加是主要原因。EV 患者的平均每例检出腺瘤数量、无蒂锯齿状息肉、左侧、微小、小腺瘤和癌症的检出率更高（癌症 4.1%比 2.3%，P=0.02）。EV 切除率为 4.1%。EAC 使插管时间缩短了一分钟（P=0.001），但盲肠插管率或退出时间没有差异。EAC 耐受良好，但在没有或很少镇静的情况下进行结肠镜检查时，插入肛门时会引起轻微不适。EV 无明显不良事件。
EV 显著提高了结直肠癌筛查患者的 ADR，应使用 EV 来提高结肠镜检查的检出率。
NCT02552017，结果；ISRCTN11821044，结果。
