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临床试验/NCT02811419
NCT02811419已完成不适用

I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2017年2月1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
740
试验地点
2
主要终点
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected

研究概览

简要总结

This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps.

详细描述

This is a randomized controlled trial comparing the use of i-scan (digital surface and contrast enhancement of the mucosa) versus standard high-definition white light for the detection of conventional adenomas and sessile serrated adenomas/polyps. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as sessile serrated adenomas/polyps (SSA) are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Recent studies have shown that image enhanced endoscopy can highlight the appearance of these lesions. This study will test whether i-scan increases the detection of conventional adenomas and sessile serrated adenomas/polyps in a randomized controlled trial.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 50-75
  • Intact colon and rectum
  • Willing to sign an informed consent form

排除标准

  • Subjects less than 50 years of age or greater than 75 years of age
  • Subjects who are in the inpatient unit
  • Subjects with diverticulitis,
  • Subjects with inflammatory bowel disease
  • Subjects with polyposis syndromes
  • Subjects with previous surgical resection of any portion of the colon or rectum
  • Subjects referred for endoscopic resection of previously diagnosed colorectal polyp

研究组 & 干预措施

i-scan

Active Comparator

Inspection with i-scan surface enhancement

干预措施: i-scan (Device)

Standard high-definition white light

Active Comparator

Inspection with standard high-definition white light (usual care)

干预措施: standard high-definition white light (Device)

结局指标

主要结局

Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected

时间窗: 12 months

次要结局

  • Number of Participants With Conventional Adenoma Detected(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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