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Papillary Epinephrine Injection Combined With Rectal Indomethacin

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

Last updated 2025-09-15

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 that are included in the guideline recommendations, but despite the frequent use of these methods, the incidence rates are still more than acceptable. 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 be a method that meets these goals. Ampullary epinephrine injection is an effective method in terms of post sphincterotomy bleeding but to our knowledge, there is no study examining its efficacy in PEP prophylaxis except for one retrospective study that we reported.

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

Given this information, we designed a large-scale, double-blind, randomized, controlled, superiority trial.

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

DRUG

Papillary epinephrine injection combined with rectal indomethacin

All patients in this group receive preprocedural 100mg indomethacin spp and post-procedure 4 ml of undiluted epinephrine injected around the duodenal papilla on four quadrants, over a period of 60 seconds using a sclerotherapy needle

DRUG

Rectal indomethacin alone

All patients in this group receive preprocedural 100mg indomethacin spp

Sponsors & Collaborators

  • Duzce University

    lead OTHER

Principal Investigators

  • Salih Tokmak · Duzce University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-02-01
Completion
2023-04-01

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