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临床试验/NCT03696992
NCT03696992已完成不适用

Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective Randomized Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 884 人开始时间: 2018年11月8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
884
试验地点
1
主要终点
Proximal adenoma detection rate

研究概览

简要总结

This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.

详细描述

Study population:

Consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2.

Study design and randomization:

This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (ELUXEO endoscopic system) vs NBI (290 video system) vs WLI which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The three groups are: (1) NBI follow by WLI; (2) BLI follow up WLI; (3) WLI follow by WLI. Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes. The patients are blinded to the group assignment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

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

入选标准

  • Age 40 or above
  • scheduled for colonoscopy

排除标准

  • unable to provide informed consent
  • have undergone previous colorectal resection,
  • personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes.
  • Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses
  • poor bowel preparation

结局指标

主要结局

Proximal adenoma detection rate

时间窗: one day

proportion of patients with proximal adenoma detected on first examination

次要结局

  • proximal polyp detection rate(one day)
  • proximal polyp miss rate(one day)
  • proximal adenoma miss rate(one day)

研究者

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

LEUNG Wai Keung

Professor

The University of Hong Kong

研究点 (1)

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