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Papillary Epinephrine Injection vs Rectal Indomethacin

NCT07173179 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2026-07-17

No results posted yet for this study

Summary

Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common and one of the most undesirable major adverse events after endoscopic retrograde cholangiopancreatography (ERCP), causing significant morbidity and even mortality. The incidence rate is almost 15% in high-risk patients and no less than 3% in average-risk patients.

Many factors contribute to PEP, such as patient-related and endoscopist-related factors, but mainly two mechanisms are considered in terms of physiopathology: papillary edema caused by mechanical trauma during cannulation and thermal injury with electrocautery current.

Rectal NSAIDs and pancreatic stent placement are the two proven methods of PEP prophylaxis included in the guideline recommendations, but despite their frequent use, the incidence rates remain unacceptably high. There is a need for additional methods that are easy to implement, preferably low-cost, and safe to reduce the risk of PEP.

Topical epinephrine applied submucosally can meet these goals. Ampullary epinephrine injection is an effective method for post-sphincterotomy bleeding. Still, to our knowledge, no study has examined its efficacy in PEP prophylaxis, except for the retrospective study we reported.

There are conflicting reports on epinephrine spraying onto the papilla for PEP, but these trials are largely heterogeneous, with different dose regimens. It should also be noted that spraying epinephrine onto the papilla has a duration of action of about 1 to 5 minutes, whereas epinephrine injection has a duration of roughly 120 minutes.

Given this information, a large-scale, prospective, double-blind, randomized, controlled trial is designed.

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

PROCEDURE

Epinephrine injection

The patients will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice, at the end of the procedure, in 60 seconds

DRUG

Indomethacin

The patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure

Sponsors & Collaborators

  • Duzce University

    lead OTHER

Principal Investigators

  • Salih Tokmak · Duzce University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-03-01
Completion
2025-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173179 on ClinicalTrials.gov