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临床试验/NCT03336359
NCT03336359已完成不适用

Tandem Colonoscopy Study of Linked Color Imaging Versus Narrow Band Imaging on Colorectal Adenoma Detection: A Prospective, Randomized Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2017年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
272
试验地点
1
主要终点
Adenoma/polyp detection rate

研究概览

简要总结

This is a prospective randomized trial comparing the adenoma detection rate of LCI with NBI. Eligible patients are randomly allocated in a 1:1 ratio to undergo tandem colonoscopy with LCI (LCI group) or NBI (NBI group). 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).

The primary outcome of this study is to compare the adenoma or polyp detection rates by LCI and NBI during the first examination. Secondary outcomes included adenoma/polyp miss rate by LCI or NBI. Other outcomes include sessile serrated adenomas or polyps (SSA/P) detection rates and advanced adenoma detection rates.

详细描述

Study design and randomization:

This is a prospective randomized head-to-head trial comparing the adenoma detection rate of LCI with NBI. Eligible patients are randomly allocated in a 1:1 ratio to undergo tandem colonoscopy with LCI (LCI group) or NBI (NBI group). 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 and the LASEREO endoscopic system (Fujifilm Co, Tokyo, Japan) or the EVIS- EXERA 290 video system (Olympus Optical, Tokyo, Japan).

Colonoscopy:

Patients are instructed to take low-residue diet two days before colonoscopy. Oral polyethylene glycol lavage solution is used for bowel preparation (routine bowel preparation). The assigned endoscopic system will be used and the colonoscope will advance to cecum under WL in all patients. Cecal intubation is confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. Once cecal intubation is performed, the colonoscope is withdrawn to the anus under LCI or NBI accordingly. All detected polyps will be removed during this examination. The withdrawal time of the first pass (minus the polypectomy site) will be measured by a stopwatch.

The size (measured with biopsy forceps), location, and morphology of polyps are recorded by an independent observer. The Boston Bowel Preparation Scale score is evaluated during examination.

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
None

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

  • Consecutive adult patients undergoing outpatient colonoscopy
  • aged 40 or above

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
  • considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses
  • cecum could not be intubated for various reasons or due to poor bowel preparation

研究组 & 干预措施

LCI

Active Comparator

Tandem colonoscopy with Linked Color Imaging system

干预措施: Tandem colonoscopy (Diagnostic Test)

NBI

Active Comparator

Tandem colonoscopy with Narrow band imaging system

干预措施: Tandem colonoscopy (Diagnostic Test)

结局指标

主要结局

Adenoma/polyp detection rate

时间窗: first-pass colonoscopy

Percentage of patients with adenoma/polyp detected

次要结局

  • Adenoma/polyp miss rate(second-pass colonoscopy)

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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