Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.

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Key information

Conditions

Colon Cancer Adenoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp Polyps

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing screening colonoscopy

Exclusion criteria

Age < 50
Prior colon resection
Inflammatory bowel disease
Prior colonoscopy or sigmoidoscopy
More than one first-degree relative with colon cancer

Treatment and study plan

Chromocolonoscopy

Procedure

Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

Primary outcomes

Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.

Time frame: Cross-sectional prevalence of adenomas between the 2 study groups

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

American College of Gastroenterology
Stony Brook University
University of Chicago

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Oct 28, 2005
Registry last updated: Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed