Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 37
- Locations
- 5
- Primary Endpoint
- Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
- •Spigelman score of duodenal adenoma equal to II or III
Exclusion Criteria
- •Incapability of signing informed consent
- •Active gastric or duodenal ulcer, gastrointestinal bleeding
- •Cardiovascular disease or risk:
- •Congestive cardiac failure: NYHA class II to IV
- •Proven ischemic heart disease and/or cerebrovascular disease
- •Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members \<55 years)
- •Renal dysfunction: creatinine clearance below 50mL/min
- •Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
- •Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
- •Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
Arms & Interventions
Group 1
Patients receive oral celecoxib twice daily and oral placebo twice daily
Intervention: Celecoxib (Drug)
Group 1
Patients receive oral celecoxib twice daily and oral placebo twice daily
Intervention: Placebo (Drug)
Group 2
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
Intervention: Celecoxib (Drug)
Group 2
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
Intervention: Ursodeoxycholic acid (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cell proliferation, in normal mucosa and adenomas (if present)(Baseline, 6 months)
- Biliary acid profile (if present)(Baseline, 6 months)