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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

A randomized trial to study the effect of primary precut papillotomy versus primary precut fistulotomy on post ERC pancreatitis (PEP) rate among high risk cohort for PEP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031004
Enrollment
324
Registered
2021-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: K831- Obstruction of bile duct

Interventions

Intervention1: Primary precut fistulotomy: In this group, we will start ERC upfront by performing primary precut fistulotomy without attempting standard cannulation method. This will be done with the

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To compare the effect of primary PP with primary PF on PEP rate in high risk cohort for PEPTimepoint: 1 day—

Secondary

MeasureTime frame
1-Compare the success rate of selective biliary cannulation (SBC) 2-Compare the rate of other ERC related complications 3-Compare the total procedure time (starting from precut to successful SBC) 4-Need for other interventions 5-Compare the rate of hyperamylasemiaTimepoint: 3 days—

Countries

India

Contacts

Public ContactHarshal S Mandavdhare

PGIMER

hmandavdhare760@gmail.com9592814877

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026