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

Ampullary Adenoma Clinical Trial

— ERASE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216730
• Other study ID #: ERASE- pilot
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: January 20, 2025

Study information

• Verified date: January 2024
• Source: Asian Institute of Gastroenterology, India
• Contact: Sonam Mathur, MD
• Phone: 9182645727
• Email: Drsonam[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 20, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Ampullary Adenoma
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)