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临床试验/NCT02880748
NCT02880748Unknown不适用

Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
450
试验地点
1
主要终点
Adenoma miss rate

研究概览

简要总结

Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.

详细描述

For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.

For the AI method, water was not used, and air was insufflated during insertion.

Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 patients undergoing selective polypectomy

排除标准

  • Polyps found more than 6 months
  • Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
  • Patients with history of inflammatory bowel disease
  • Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
  • Patients not undergoing standard bowel preparation
  • Patients with solid feces in the last stool after bowel preparation
  • Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
  • Hemodynamically unstable
  • Pregnant women
  • Unable to provide informed consent

结局指标

主要结局

Adenoma miss rate

时间窗: 12 months

Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.

次要结局

  • Adenoma per positive patient (APP)(12 months)
  • Quality of Bowel Preparation(12 months)
  • Pain Scores on the Visual Analog Scale compared with previous colonoscopy(12 months)
  • adenoma-level miss rate(12 months)
  • Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy(12 months)
  • Complication rate(12 months)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Associated professor

Air Force Military Medical University, China

研究点 (1)

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