Risk Factors for Post-ERCP Pancreatitis: A Prospective Multicenter Study

Chi-Liang Cheng, M.D.; Stuart Sherman, M.D.; James L. Watkins, M.D.; Jeffrey Barnett, M.D.; Martin Freeman, M.D.; Joseph Geenen, M.D.; Michael Ryan, M.D.; Harrison Parker, M.D.; James T. Frakes, M.D.; Evan L. Fogel, M.D.; William B. Silverman, M.D.; Kulwinder S. Dua, M.D.; Giuseppe Aliperti, M.D.; Paul Yakshe, M.D.; Michael Uzer, M.D.; Whitney Jones, M.D.; John Goff, M.D.; Laura Lazzell-Pannell, RN; Abdullah Rashdan, M.D.; M'hamed Temkit, MS; Glen A. Lehman, M.D.

Disclosures

Am J Gastroenterol. 2006;101(1):139-147. 

In This Article

Abstract and Introduction

Objectives: Pancreatitis is the most common and serious complication of diagnostic and therapeutic ERCP. The aim of this study is to examine the potential patient- and procedure-related risk factors for post-ERCP pancreatitis in a prospective multicenter study.
Methods: A 160-variable database was prospectively collected by a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group and participating in a randomized controlled study evaluating whether prophylactic corticosteroids will reduce the incidence of post-ERCP pancreatitis. Data were collected prior to the procedure, at the time of procedure, and 24–72 h after discharge. Post-ERCP pancreatitis was diagnosed and its severity graded according to consensus criteria.
Results: Of the 1,115 patients enrolled, diagnostic ERCP with or without sphincter of Oddi manometry (SOM) was performed in 536 (48.1%) and therapeutic ERCP in 579 (51.9%). Suspected sphincter of Oddi dysfunction (SOD) was the indication for the ERCP in 378 patients (33.9%). Pancreatitis developed in 168 patients (15.1%) and was graded mild in 112 (10%), moderate in 45 (4%), and severe in 11(1%). There was no difference in the incidence of pancreatitis or the frequency of investigated potential pancreatitis risk factors between the corticosteroid and placebo groups. By univariate analysis, the incidence of post-ERCP pancreatitis was significantly higher in 19 of 30 investigated variables. In the multivariate risk model, significant risk factors with adjusted odds ratios (OR) were: minor papilla sphincterotomy (OR: 3.8), suspected SOD (OR: 2.6), history of post-ERCP pancreatitis (OR: 2.0), age <60 yr (OR: 1.6), ≥2 contrast injections into the pancreatic duct (OR: 1.5), and trainee involvement (OR: 1.5). Female gender, history of recurrent idiopathic pancreatitis, pancreas divisum, SOM, difficult cannulation, and major papilla sphincterotomy (either biliary or pancreatic) were not multivariate risk factors for post-ERCP pancreatitis.
Conclusion: This study emphasizes the role of patient factors (age, SOD, prior history of post-ERCP pancreatitis) and technical factors (number of PD injections, minor papilla sphincterotomy, and operator experience) as the determining high-risk predictors for post-ERCP pancreatitis.

Pancreatitis is the most common and feared complication of ERCP, occurring in up to 30–40% of high-risk patients.[1–3] It is associated with substantial morbidity and occasional mortality. There have been ongoing efforts to minimize the incidence and severity of post-ERCP pancreatitis. Precise identification of risk factors for post-ERCP pancreatitis is essential to recognize high-risk cases in which ERCP should be avoided if possible, or in which protective endoscopic or pharmacologic interventions should be considered.[2,4] The mechanisms that lead to post-ERCP pancreatitis are not fully understood but believed to be multifactorial (mechanical, chemical, hydrostatic, enzymatic, microbiologic, and thermal), and the triggering event is thought to cause premature intracellular activation of proteolytic enzymes within acinar cells resulting in cellular injury and autodigestion of pancreatic tissue.[1,5]

A number of specific risk factors, acting independently or in concert, have been proposed as predictors of post-ERCP pancreatitis. These include both patient- and procedure-related factors. However, the reported risk factors vary widely from study to study. These discrepancies may be attributable to heterogeneous patient populations, differing levels of endoscopic expertise, varying cannulation techniques, and disparate definition of post-ERCP pancreatitis. More important, the use of univariate analysis to identify risk factors for post-ERCP pancreatitis may produce misleading results because of inability to sort out confounding variables.[6–10] Recent studies have used multivariate analysis as a tool to identify and quantify the effect of multiple potentially confounding risk factors.[11–20]

The aim of this study was to use multivariate analysis and examine the independent risk factors for post-ERCP pancreatitis in a group of patients who were prospectively randomized to receive prophylactic corticosteroids or placebo in a double-blinded, multicenter, controlled clinical trial.

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