Clinical Trial: Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)
Brief Summary: Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.
Detailed Summary:
Sponsor: Radboud University
Current Primary Outcome: Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures) [ Time Frame: Baseline, 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cell proliferation, in normal mucosa and adenomas (if present) [ Time Frame: Baseline, 6 months ]
- Biliary acid profile (if present) [ Time Frame: Baseline, 6 months ]
Original Secondary Outcome:
- Cell proliferation, in normal mucosa and adenomas (if present) [ Time Frame: Baseline, 6 months ]
- Biliary acid profile [ Time Frame: Baseline, 6 months ]
Information By: Radboud University
Dates:
Date Received: December 15, 2008
Date Started: May 2009
Date Completion:
Last Updated: May 15, 2013
Last Verified: August 2010
