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Clinical Trial: Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in FAP Patients.
This study is currently recruiting patients.
Verified by Hospital of Paris August 2004
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Adenomatous Polyposis Coli Adenoma | Drug: Ursodeoxycholic acid | Phase II Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Colorectal Cancer; Digestive Diseases; Genetic Disorders
Genetics Home Reference related topics: familial adenomatous polyposis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF
Secondary Outcomes: Cellular proliferation (Ki 67 and PCNA).; Biliary acid profil.; Compliance to the treatment.
Expected Total Enrollment: 100
Study start: October 2004; Expected completion: December 2008
Last follow-up: October 2008; Data entry closure: November 2008
We designed a randomized double blinded study to evaluate the efficiency of UDCA in the treatment of this 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 endoscopies, blood samples are collected for biliary acid profil analysis. Moreover, during endoscopies, duodenal fluid and ileal fluid are collected for biliary acid profil analysis, also.
At the end of the follow-up of the last patients included (nov 2008), biliary acid profil analysis will be performed and statistical analysis of the results will be perform.
Eligibility
Inclusion Criteria:
- Male or female patients between 18 and 65 years
- Weight inferior or egal to 100 kg
- Restorative proctocolectomy
- APC mutation identified or more than 100 polyps on the colectomy specimen
- Spigelman score of duodenal adenoma superior or egal to 1
- Efficient contraceptive treatment for pre-menopausal woman
- Cooperative patient
- Signed consent
- Social security insurance
Exclusion Criteria:
- Spigelman score of duodenal adenoma egal to 4 with severe dysplasia
- Hepatic disease
- Intramesenteric desmoid tumour
- Any severe disease
-
Daily use during the last 3 months of:
- aspirin
- Non-steroid anti-inflammatory drugs
- tamoxifen
- Cholesteramin
- Pregnancy
- Breath feeding
Location and Contact Information
Tabassome Simon, M.D., Ph.D. 0033 1 49 28 22 02 urcest@chusa.jussieu.fr
France
Saint-Antoine Hospital, Paris, 75012, France; Recruiting
Tabassome Simon, M.D., Ph.D. 0033 1 49 28 22 02 urcest@chusa.jussieu.fr
Yann RA Parc, M.D., Ph.D., Principal Investigator
Yann RA Parc, M.D., Ph.D., Principal Investigator, 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
Spigelman AD, Williams CB, Talbot IC, Domizio P, Phillips RK. Upper gastrointestinal cancer in patients with familial adenomatous polyposis. Lancet. 1989 Sep 30;2(8666):783-5.
Nugent KP, Farmer KC, Spigelman AD, Williams CB, Phillips RK. Randomized controlled trial of the effect of sulindac on duodenal and rectal polyposis and cell proliferation in patients with familial adenomatous polyposis. Br J Surg. 1993 Dec;80(12):1618-9.
Jarvinen HJ, Nyberg M, Peltokallio P. Biliary involvement in familial adenomatosis coli. Dis Colon Rectum. 1983 Aug;26(8):525-8.
Spigelman AD, Owen RW, Hill MJ, Phillips RK. Biliary bile acid profiles in familial adenomatous polyposis. Br J Surg. 1991 Mar;78(3):321-5.
Mower HF, Ray RM, Shoff R, Stemmermann GN, Nomura A, Glober GA, Kamiyama S, Shimada A, Yamakawa H. Fecal bile acids in two Japanese populations with different colon cancer risks. Cancer Res. 1979 Feb;39(2 Pt 1):328-31.
Hill MJ, Drasar BS, Williams RE, Meade TW, Cox AG, Simpson JE, Morson BC. Faecal bile-acids and clostridia in patients with cancer of the large bowel. Lancet. 1975 Mar 8;1(7906):535-9.
Tanida N, Hikasa Y, Shimoyama T, Setchell KD. Comparison of faecal bile acid profiles between patients with adenomatous polyps of the large bowel and healthy subjects in Japan. Gut. 1984 Aug;25(8):824-32.
van der Werf SD, Nagengast FM, van Berge Henegouwen GP, Huijbregts AW, van Tongeren JH. Colonic absorption of secondary bile-acids in patients with adenomatous polyps and in matched controls. Lancet. 1982 Apr 3;1(8275):759-62. No abstract available.
Wilpart M, Mainguet P, Maskens A, Roberfroid M. Structure-activity relationship amongst biliary acids showing comutagenic activity towards 1,2-dimethylhydrazine. Carcinogenesis. 1983 Oct;4(10):1239-41.
Earnest DL, Holubec H, Wali RK, Jolley CS, Bissonette M, Bhattacharyya AK, Roy H, Khare S, Brasitus TA. Chemoprevention of azoxymethane-induced colonic carcinogenesis by supplemental dietary ursodeoxycholic acid. Cancer Res. 1994 Oct 1;54(19):5071-4.
Serfaty L, De Leusse A, Rosmorduc O, Desaint B, Flejou JF, Chazouilleres O, Poupon RE, Poupon R. Ursodeoxycholic acid therapy and the risk of colorectal adenoma in patients with primary biliary cirrhosis: an observational study. Hepatology. 2003 Jul;38(1):203-9.
Parc Y, Piquard A, Dozois RR, Parc R, Tiret E. Long-term outcome of familial adenomatous polyposis patients after restorative coloproctectomy. Ann Surg. 2004 Mar;239(3):378-82.
Last Updated: August 24, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134758
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-08-30
Resources
- Calcium Pantothenate (Drug Digest)
- Pantothenic Acid (Drug Digest)
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