Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients
Adenomatous Polyposis Coli, Familial
About this trial
This is an interventional treatment trial for Adenomatous Polyposis Coli, Familial focused on measuring Treatment of adenomas of the duodenum in FAP patients., Adenoma
Eligibility Criteria
Inclusion Criteria: Male or female patients between 18 and 65 years of age Weight less than or equal to 100 kg Restorative proctocolectomy Activated protein C (APC) mutation identified or more than 100 polyps on the colectomy specimen SPIGELMAN score of duodenal adenoma greater than or equal to 1 Efficient contraceptive treatment for pre-menopausal women Cooperative patient Signed consent Social security insurance Exclusion Criteria: SPIGELMAN score of duodenal adenoma equal to 4 with severe dysplasia Hepatic disease Intermesenteric desmoid tumour Any severe disease Daily use during the last 3 months of: aspirin; non-steroid anti-inflammatory drugs; tamoxifen; cholestyramine. Pregnancy Breast-feeding
Sites / Locations
- Saint-Antoine Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Ursodeoxycholic acid during 2 years : between 40 and 50 kg : 500 mg/day between 51 and 75 kg : 750 mg/day between 76 and 100 kg : 1000 mg/day