Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis (PreDuoFAP)
Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps
About this trial
This is an interventional prevention trial for Familial Adenomatous Polyposis focused on measuring Familial adenomatous polyposis, Adenomatous Polyposis Coli, Digestive System Neoplasms, Gastrointestinal Disease, Intestinal disease, Intestinal neoplasms, Gastrointestinal neoplasms, Polyps, Adenoma, Adenomatous Polyps, Neoplastic Syndromes, Hereditary, Digestive System Diseases, Genetic Diseases, Inborn, Chemoprevention, Celecoxib, Ursodeoxycholic acid, Anti-Inflammatory agents, Non-Steroidal, Cyclooxygenase Inhibitors
Eligibility Criteria
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
- Use of lithium
- Symptomatic gallstones
- Inflammatory bowel disease
- (Possible) pregnancy or breast feeding
Sites / Locations
- Academic Medical Center
- University Medical Center
- Leiden University Medical Center
- University Medical Center St. Radboud
- Erasmus Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group 1
Group 2
Patients receive oral celecoxib twice daily and oral placebo twice daily
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily