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

NCT06216730 | Unknown

• 1 other identifier: ERASE- pilot
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ampullary Adenoma

Outcome Measures

Primary Outcomes (1)

• Primary outcome will be safety i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis (at 9 months follow-up).

  rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis (at 9 months follow-up).

  1 YEAR(2024-2025)

Study Arms (1)

single arm cohort study

OTHER

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

Procedure: Endoscopic papillectomy

Interventions

Endoscopic papillectomy 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.

single arm cohort study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Papillary adenoma which seems suitable for curative endoscopic resection.
• years or older.
• Capable of providing written and oral informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Central Study Contacts

Sonam Mathur, MD

CONTACT

9182645727; Drsonam@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: February 5, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 20, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share