NCT06216730

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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-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. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension

Conditions

• Ampullary Adenoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-01-10
• Completion: 2025-01-20
• First posted: 2024-01-22
• Last updated: 2024-01-22