Status:
COMPLETED
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Familial Adenomatous Polyposis
Duodenal Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine we...
Eligibility Criteria
Inclusion
- Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
- Spigelman score of duodenal adenoma equal to II or III
Exclusion
- Incapability of signing informed consent
- Active gastric or duodenal ulcer, gastrointestinal bleeding
- Cardiovascular disease or risk:
- Congestive cardiac failure: NYHA class II to IV
- Proven ischemic heart disease and/or cerebrovascular disease
- Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members \<55 years)
- Renal dysfunction: creatinine clearance below 50mL/min
- Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
- Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
- Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
- Use of lithium
- Symptomatic gallstones
- Inflammatory bowel disease
- (Possible) pregnancy or breast feeding
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00808743
Start Date
May 1 2009
End Date
January 1 2013
Last Update
May 16 2013
Active Locations (5)
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1
Academic Medical Center
Amsterdam, Netherlands
2
University Medical Center
Groningen, Netherlands
3
Leiden University Medical Center
Leiden, Netherlands
4
University Medical Center St. Radboud
Nijmegen, Netherlands