Prevention of progression of duodenal adenomas to cancer in patients with familial adenomatous polyposis - Duodenal adenomas and cancer in patients with FAP
- Conditions
- Familial Adenomatous PolyposisDuodenal adenomas and carcinomas
- Registration Number
- EUCTR2008-003696-43-NL
- Lead Sponsor
- KWF Kankerbestrijding
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients with FAP with duodenal adenomas Spigelman stage II and III, under regular controle in one of 4 participating University hospitals.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- History of cardiovascular incident
- Cholelithiasis
- History of gastric or duodenal ulcera
- Allergic reaction to NSAIDs or UDCA
- Renal function disturbance, creat clearance <50ml/min
- Liver function disturbance, albumin <25g/l or Child-Pugh-score > or = 10
- Use of NSAIDs or UDCA during enrolment
- Cardiac patients NYHA class II-IV
- Age below 18 or above 70 years or incapable of signing informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method