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临床试验/NCT04214678
NCT04214678已完成不适用

DeFect cLOsure After Colonic ESD With underwaTer Technique Versus Conventional Clip : a Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Time required to complete clip closure of mucosal defect

研究概览

简要总结

This is a single centre randomised controlled study comparing underwater clip closure versus conventional gas insufflation clip closure of post-resection defect in patients undergoing colonic endoscopic resection. The investigators hypothesize that underwater clip closure would be faster than conventional closure under gas insufflation.

详细描述

Endoscopic submucosal dissection (ESD) is a minimally invasive technique that has been increasingly applied to superficial colorectal tumours over the past two decades (1, 2). Although serious complications with this procedure are uncommon, both significant delayed haemorrhage (1-2%) and perforation (4-6%) are recognised complications (3). Although perforation is generally recognised and treated at time of endoscopy, delayed bleeding often requires repeat readmission and endoscopy for haemorrhage control. There is growing evidence to support prophylactic clip closure of mucosal defects to reduce incidences of delayed haemorrhage.

Prophylactic clip closure of mucosal defects (≥20mm) after colonic ESD is supported by large retrospective case series. In a series of 524 lesions in 463 patients, Liaquat et al. (2013) reported prophylactic clipping of resection sites to close mucosal defects versus non-closure, reduced delayed haemorrhage (9.7% vs 1.8%) (4). Ogiyama et al. (2018) reported similar findings in a series of 156 lesions (0% vs 8.2%, p=0.008) (5).

Prophylactic defect closure also has a theoretical benefit in reducing delayed perforation from unrecognised muscular breach during dissection. Though it is recognised that there is a paucity of evidence to support mucosal apposition in reducing delayed perforation rates (~0.2%) (3). This is likely due to the underpowered published studies and a very low event rate.

For these reasons, it has been routine practice of many endoscopists for clip closure of mucosal defects after endoscopic resection of large colorectal neoplasia. However, this technique remains technically challenging within the narrow colonic space and at times may not be feasible. The 'underwater closure technique' in mucosal defect closure of colonic and duodenal endoscopic resections has promising early results. Compared to conventional CO2 insufflation clip placement, at the time of mucosal closure this technique applies luminal water infusion to 'float' the resection borders and downsize the target. Early experience suggests this technique facilitates easier apposition of resection borders and complete closure. There are currently no randomized trials comparing these clip closure techniques.

The aim of the study is to evaluate whether prophylactic underwater closure technique facilitates easier ESD mucosal defect closure compared to conventional clip closure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective endoscopic resection
  • Colorectal superficial neoplasm with a resultant mucosal defect of ≥20mm
  • Age >18 years old

排除标准

  • Patients on anticoagulation (Warfarin or other direct oral anticoagulants)
  • Muscular perforation during the endoscopic resection
  • Incomplete endoscopic resection
  • Lesions arising from surgical anastomotic site
  • Marked electrolyte abnormalities
  • Other cases deemed by the examining physician as unsuitable for safe treatment
  • Patients who refused to participate

结局指标

主要结局

Time required to complete clip closure of mucosal defect

时间窗: Within 1 hour

o Defined as the time from completion of prophylactic coagulation till the final clip application (min)

次要结局

  • Total time for endoscopic procedure (min)(Within 1 hour)
  • Number of endoscopic clip used for closure(Within 1 hour)
  • Rate of Haemorrhage(30 days)
  • Rate of Any other adverse event related to the procedure(30 days)
  • Technical success of complete closure of defect (%)(Within 1 hour)
  • Rate of Perforation(30 days)
  • Rate of Post-polypectomy electrocoagulation syndrome(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hon Chi Yip

Associate Consultant

Chinese University of Hong Kong

研究点 (1)

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