Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenomatous Polyposis Coli, Familial |
Drug: Ursodeoxycholic acid Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF |
- SPIGELMAN severity score of duodenal lesion after 2 years of follow-up [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ]
- Cellular proliferation (Ki 67 and PCNA) [ Time Frame: At the baseline, 1 and 2 years ] [ Designated as safety issue: No ]
- Biliary acid profile [ Time Frame: At the baseline, 1 and 2 years ] [ Designated as safety issue: No ]
- Compliance to the treatment [ Time Frame: Every 6 months during 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 90 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | October 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Ursodeoxycholic acid during 2 years :
|
Drug: Ursodeoxycholic acid
During 2 years :
Other Name: Delursan
|
| Placebo Comparator: 2 |
Drug: Placebo
During 2 years :
Other Name: Placebo
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Saint-Antoine Hospital | |
| Paris, France, 75012 | |
| Principal Investigator: | Yann RA Parc, M.D., Ph.D. | 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Christophe Aucan, Department of clinical research and development |
| ClinicalTrials.gov Identifier: | NCT00134758 History of Changes |
| Other Study ID Numbers: | P030419, AOM 03041 |
| Study First Received: | August 23, 2005 |
| Last Updated: | July 28, 2009 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Treatment of adenomas of the duodenum in FAP patients. Adenoma |
Additional relevant MeSH terms:
|
Adenoma Adenomatous Polyposis Coli Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenomatous Polyps Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Colonic Neoplasms |
Neoplastic Syndromes, Hereditary Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Intestinal Polyposis Genetic Diseases, Inborn Ursodeoxycholic Acid Cholagogues and Choleretics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013