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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134758

Enrollment

Registered

2005-08-25

Start date

2004-10-31

Completion date

2009-10-31

Last updated

2009-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatous Polyposis Coli, Familial

Keywords

Treatment of adenomas of the duodenum in FAP patients., Adenoma

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 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.

Interventions

DRUGUrsodeoxycholic 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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
SPIGELMAN severity score of duodenal lesion after 2 years of follow-up	Baseline, 1 and 2 years

Secondary

Measure	Time frame
Cellular proliferation (Ki 67 and PCNA)	At the baseline, 1 and 2 years
Biliary acid profile	At the baseline, 1 and 2 years
Compliance to the treatment	Every 6 months during 2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026