Papillary Epinephrine Injection vs Rectal Indomethacin

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.

NCT Number	NCT07173179
Lead Sponsor	Duzce University
Conditions	Post-ERCP Acute Pancreatitis
Enrollment	504 participants
Start Date	2023-01-01
Primary Completion	2025-03-01 (estimated)
Study Completion	2025-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-17