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

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00245492
• Collaborator: American College of Gastroenterology (Other), Stony Brook University (Other), University of Chicago (Other)
• Enrollment: 792
• Locations: 3
• Arm: 1
• Duration (Months): 31
• Patients Per Site: 264
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer; Polyp; Adenoma	Procedure: Chromocolonoscopy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 792 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Chromocolonoscopy	Procedure: Chromocolonoscopy; Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

Outcome Measures

Primary Outcome Measures

1. Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. [Cross-sectional prevalence of adenomas between the 2 study groups]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202
2	Roudebush VA Medical Center	Indianapolis	Indiana	United States
3	SUNY Stony Brook	Stony Brook	New York	United States

Sponsors and Collaborators

• Indiana University
• American College of Gastroenterology
• Stony Brook University
• University of Chicago

Investigators

• Principal Investigator: Charles J Kahi, MD, Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00245492
• Other Study ID Numbers: 0508-64; 2005ACG-100CRC
• First Posted: Oct 28, 2005
• Last Update Posted: Jan 28, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Colonoscopy; Chromoscopy; Prevention
• Additional relevant MeSH terms: Adenoma

Study Results

No Results Posted as of Jan 28, 2009