A randomised trial to study the effect of precut techniques as primary modality on post ERC pancreatitis (PEP) rate among those who come under high risk for PEP

Completed

• Conditions: Obstruction of bile duct,

• Registration Number: CTRI/2021/02/031004
• Lead Sponsor: PGIMER

Brief Summary

Post ERCP pancreatitis (PEP) is the most common and worrisome complication of ERCP with an incidence ranging from 3.5-9.7%. Among the high-risk group for PEP the incidence reported is around 14.7%. As per ESGE guidelines 2020 a patient is considered to be high risk for PEP in presence of at least 1 definite or 2 likely patient /procedure related risk factors. A recent multicenter randomized trial has shown very good efficacy and safety of primary precut fistulotomy in high risk cohort for PEP. Another randomized trial compared very early precut papillotomy (PP) with primary PP. The primary PP group had only 1 case of PEP (0.67%), suggesting good safety of the primary PP approach, although the very early group had PEP rate of 5.2%, same as has been reported in standard cannulation. In the second study the PP was done in average risk patients and even among them the PEP rate in the very early group was 5.2%. We do not know what is role of primary PP in high risk cohort for PEP, hence, we planned this randomized trial to compare the effect of primary PP with primary PF on PEP rate in high risk cohort for PEP.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-02
• Study Completion: 2024-10-06
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

Patients undergoing ERC and come under high risk group for development of PEP will be randomised into either primary precut fistulotomy or paplillotomy groups.

Exclusion Criteria

1-Previous sphincterotomy 2-Severe coagulopathy (INR>1.5) 3-Suspected periampullary growth 4-Distorted anatomy-Billroth II surgery 5-Small flat papilla 6-Periampullary diverticulum other than type III 7-Pancreatitis (Acute/chronic) 8- Unwilling to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of primary PP with primary PF on PEP rate in high risk cohort for PEP	1 day

Secondary Outcome Measures

Name	Time	Method
1-Compare the success rate of selective biliary cannulation (SBC)	2-Compare the rate of other ERC related complications

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Harshal S Mandavdhare

Principal investigator

9592814877

hmandavdhare760@gmail.com