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

NCT ID: NCT06216730

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2025-01-20

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-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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm cohort study

Since this is a single arm cohort study the outcomes will be descriptive

Group Type: OTHER

Endoscopic papillectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sonam Mathur, MD

Role: CONTACT

Drsonam@hotmail.com

9182645727

Other Identifiers

ERASE- pilot

Identifier Type: -

Identifier Source: org_study_id