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临床试验/NCT01572428
NCT01572428已完成不适用

Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon

Indiana University2 个研究点 分布在 1 个国家目标入组 898 人开始时间: 2011年4月最近更新:
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
898
试验地点
2
主要终点
Total Number of Serrated Lesions Proximal to the Sigmoid Colon

研究概览

简要总结

This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.

详细描述

This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination of the colon in blue light)versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). 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 serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions 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. Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions. This study will test whether Narrow-Band Imaging increases the detection of serrated lesions 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
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 50-85
  • Intact colon and rectum
  • American Society of Anesthesiology risk class 1, 2 or 3

排除标准

  • No prior surgical resection of colon or rectum

研究组 & 干预措施

Narrow-Band Imaging (NBI)

Active Comparator

Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)

干预措施: Inspection with Narrow-Band Imaging(NBI) (Procedure)

Standard White Light

Active Comparator

Inspection with Standard White Light versus Narrow-Band Imaging(NBI)

干预措施: Inspection with Narrow-Band Imaging(NBI) (Procedure)

Standard White Light

Active Comparator

Inspection with Standard White Light versus Narrow-Band Imaging(NBI)

干预措施: Standard White Light (Procedure)

结局指标

主要结局

Total Number of Serrated Lesions Proximal to the Sigmoid Colon

时间窗: During the colonoscopy procedure

Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.

Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient

时间窗: During the colonoscopy procedure

Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).

次要结局

  • Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon(During the colonoscopy procedure)
  • Total Number of Conventional Adenomas in Entire Colon(During the colonoscopy procedure)
  • Number of Conventional Adenomas Per Patient in Entire Colon(During the colonoscopy procedure)
  • Patients With 1 or More Conventional Adenomas(During the colonoscopy procedure)

研究者

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

Douglas K. Rex

Professor

Indiana University

研究点 (2)

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