True Rate of Post-ERCP Pancreatitis: Do Randomized Trials Provide the Answer?

Pancreatitis after ERCP is one of the most common and morbid adverse events following any gastrointestinal endoscopy procedure. It is imperative that the consent process for ERCP advise patients on the rate and significance of post-ERCP pancreatitis (PEP). However, identifying this rate is somewhat challenging because the risk of PEP varies based on patient characteristics, operator experience and skill, and the definition of PEP. Thus, any data that attempt to bring clarity to the true rate of PEP are welcome.

In this study, the authors utilized data from patients undergoing ERCP in randomized controlled trials (RCTs). In total, they identified 145 RCTs. They chose the unique approach of focusing only on patients who did not receive any pharmacologic therapy or a pancreatic stent so they could quantify a baseline PEP rate. 

Among the 19,038 patients, the overall cumulative incidence of PEP was 10.2% (95% confidence interval [CI], 9.3%-11.3%). Accepting that there is no universal definition for “high-risk” PEP, the authors utilized the definition proposed by the authors of each individual study; the cumulative PEP rate in these “high-risk” patients was 14.1% (95% CI, 11.5%-17.2%). The cumulative incidence rates of severe PEP (hospitalization for more than 10 days and/or the presence of pseudocyst, pancreatic necrosis, need for percutaneous drainage or surgery, or death) and mortality were 0.5% (95% CI, 0.3%-0.7%) and 0.2% (95% CI, 0.08%-0.3%), respectively. Interestingly, the rate of PEP in these patients who received no prophylaxis did not decrease from 1977 to 2022.