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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
37
Celecoxib: 400mg twice daily, orally, 6 months
Ursodeoxycholic acid: orally, 6 months, dosage based on body weight: below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses
Placebo: orally, 6 months, dosage based on body weight: below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses
Academic Medical Center
Amsterdam, Netherlands
University Medical Center
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
University Medical Center St. Radboud
Nijmegen, Netherlands
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
Cell proliferation, in normal mucosa and adenomas (if present)
Time frame: Baseline, 6 months
Biliary acid profile (if present)
Time frame: Baseline, 6 months
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Erasmus Medical Center
Rotterdam, Netherlands