Adenomatous Polyposis Coli, Familial Clinical Trial
Official title:
Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF
Malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy. Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.
We designed a randomized double blinded study to evaluate the efficiency of UDCA in the
treatment of duodenal adenomas. One hundred patients are planned to be included. Fifty will
receive UDCA and fifty a placebo. Three duodenoscopies are planned: one before inclusion,
one at the end of the first year of follow-up and one after two years of follow-up at the
end of the protocol. These duodenoscopies are associated to endoscopies of the ileal
reservoir performed at the time of restorative proctocolectomy and are recorded numerically.
Severity of the duodenal adenomas are evaluated according to the SPIGELMAN score. Patients
are seen every 6 months. Before each endoscopy, blood samples are collected for biliary acid
profile analysis. Moreover, during endoscopies, duodenal fluid and ileal fluid are collected
for biliary acid profile analysis, also.
At the end of the follow-up of the last patients included (nov 2008), biliary acid profile
analysis will be performed and statistical analysis of the results will be performed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment