ampullary adenoma papillary adenoma
Conditions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is safety i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis (at 9 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Curative resection rate at 3 and 9 months follow-up is included as secondary outcome. | — |
Countries
Netherlands