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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06216730
Other study ID # ERASE- pilot
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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