NL-OMON32335
Completed
Phase 3
Prevention of progression of duodenal adenomas to cancer in patients with familial adenomatous polyposis. - Duodenal adenomas and cancer in patients with FAP.
niversitair Medisch Centrum Sint Radboud0 sites120 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 120
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •\-Patients with FAP with duodenal adenomas of Spigelman stage II and III, with an indication for duodenoscopy
- •\-Patients with dyspeptic complaints with an indication for duodenoscopy, but without intestinal abnormalities.
- •\- Age between18\-70 years
Exclusion Criteria
- •\- Patients with a history of a cardiovascular accident, gallstones, gastric or duodenal ulcers, a prior allergic reaction on NSAIDs or UDCA or disturbed renal (creatinine clearance \< 50 ml/min.) or liver function (albumin \< 25 g/l or Child\-Pugh\-score \>\= 10\) will be excluded. No NSAIDs or UDCA may have been used during enrolment.
- •\- Cardiac patients NYHA class II\-IV.
- •\- Age below 18 or above 70 years or incapable to sign informed consent
Investigators
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