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Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a pilot-study

Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a pilot-study - ERASE-pilot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54139
Enrollment
10
Registered
2022-01-31
Start date
2022-05-05
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ampullary adenoma papillary adenoma

Interventions

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
Primary outcome is safety i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis (at 9 months).

Secondary

MeasureTime frame
Curative resection rate at 3 and 9 months follow-up is included as secondary outcome.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)