Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Asian Institute of Gastroenterology, India

Conditions:

Ampullary Adenoma

Eligibility:

All Genders

18-80 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...

Detailed Description

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.(16)
  • Failure to place a PD stent in patients with normal pancreatic duct anatomy.
  • Refusal to provide informed consent.

Key Trial Info

Start Date :

February 5 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 20 2025

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06216730

Start Date

February 5 2024

End Date

January 20 2025

Last Update

January 22 2024

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