Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a pilot-study
Recruiting
- Conditions
- ampullary adenomapapillary adenoma1001793410004606
- Registration Number
- NL-OMON54139
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
- Papillary adenoma which seems suitable for curative endoscopic resection.
- 18 years or older.
- Capable of providing written and oral informed consent.
Exclusion Criteria
- Patients with intraductal extension of >1 cm beyond the duodenal wall or
adenocarcinoma will be excluded since surgical resection is considered the
preferred treatment in these cases.
- Failure to place a PD stent in patients with normal pancreatic duct anatomy.
- Refusal to provide informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is safety i.e. rate of adverse events such as pancreatitis,<br /><br>bleeding, cholangitis, perforation, and papillary stenosis (at 9 months). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Curative resection rate at 3 and 9 months follow-up is included as secondary<br /><br>outcome.</p><br>