Status:
UNKNOWN
Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Conditions:
Papillary Adenoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-u...
Eligibility Criteria
Inclusion
- Papillary adenoma which seems suitable for curative endoscopic resection.
- 18 years or older.
- Capable of providing written and oral informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05339607
Start Date
May 5 2022
End Date
December 31 2023
Last Update
February 2 2023
Active Locations (1)
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1
Amsterdam UMC location VUmc
Amsterdam, Netherlands