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

NCT06216730 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-22

No results posted yet for this study

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-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed.

Conditions

  • Ampullary Adenoma

Interventions

PROCEDURE

Endoscopic papillectomy

patients undergoing endoscopic papillectomy will be included and treated according to the study algorithm. * A papillary adenoma (abnormal tissue growth/ tumour at junction of bile duct \& intestines) will be removed completely by cutting \& removing abnormal tissue growth using a flexible tube containing a camera through the mouth. * After the procedure you will be admitted in the hospital for at least 24 hours for observation, * You will be asked to use medications which decrease acid production (PPIs- proton pump inhibitors) in stomach for 2 weeks to decrease the risk of bleeding.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-01-10
Completion
2025-01-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06216730 on ClinicalTrials.gov