Neoplasms

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Digestive System Diseases

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Ear, Nose, and Throat Diseases

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Adenoma

Adenomatous Polyposis Coli

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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Pharyngeal Diseases

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Polyps

Adenomatous Polyps

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Gastrointestinal Agents

All Drugs and Chemicals

Ursodeoxycholic Acid

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

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

Ursodeoxycholic acid

During 2 years :

* between 40 and 50 kg : 2 tabs/day
* between 51 and 75 kg : 3 tabs/day
* between 76 and 100 kg : 4 tabs/day

Placebo

Yann RA Parc, M.D., Ph.D.

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.

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

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

Axcan Pharma

Assistance Publique - Hôpitaux de Paris

Christophe Aucan

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients	NCT00134758	Adenomatous Pol...	Ursodeoxycholic... Placebo	18 Years - 65 Years	Assistance Publique - Hôpitaux de Paris
Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients	NCT00134758	Adenomatous Pol...	Ursodeoxycholic... Placebo	18 Years - 65 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for adenomatous polyposis coli, familial