Clinical Trial: Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: SPIGELMAN severity score of duodenal lesion after 2 years of follow-up [ Time Frame: Baseline, 1 and 2 years ]

Original Primary Outcome: Spigelman severity score of duodenal lesion after 2 years of follow-up.

Current Secondary Outcome:

  • Cellular proliferation (Ki 67 and PCNA) [ Time Frame: At the baseline, 1 and 2 years ]
  • Biliary acid profile [ Time Frame: At the baseline, 1 and 2 years ]
  • Compliance to the treatment [ Time Frame: Every 6 months during 2 years ]


Original Secondary Outcome:

  • Cellular proliferation (Ki 67 and PCNA).
  • Biliary acid profil.
  • Compliance to the treatment.


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 23, 2005
Date Started: October 2004
Date Completion: October 2009
Last Updated: July 28, 2009
Last Verified: July 2009