Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF
18 Years
65 Years
Both
Adenomatous Polyposis Coli, Familial
Trial Information
Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
SPIGELMAN severity score of duodenal lesion after 2 years of follow-up
Outcome Time Frame:
Baseline, 1 and 2 years
Safety Issue:
No
Principal Investigator
Yann RA Parc, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Digestive Surgery, Saint-Antoine Hospital, Hospital of Paris (AP/HP), Pierre et Marie Curie University, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France
Authority:
France: Ministry of Health
Study ID:
P030419
NCT ID:
NCT00134758
Start Date:
October 2004
Completion Date:
October 2009
Related Keywords:
- Adenomatous Polyposis Coli, Familial
- Treatment of adenomas of the duodenum in FAP patients.
- Adenoma
- Adenoma
- Adenomatous Polyposis Coli
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