Long‐Term Outcomes After Endoscopic Papillary Large Balloon Dilation With Endoscopic Sphincterotomy for Difficult Biliary Stones: A Multicenter Retrospective Longitudinal Study

INTRODUCTION: Endoscopic papillary large balloon dilation (EPLBD) is currently considered the first-line treatment for difficult biliary stones (DBS). However, EPLBD alters the sphincter of Oddi's function, potentially exposing patients to cholangitis. To date, few data are available on the long-term consequences of EPLBD. AIMS AND METHODS: The aim of this study is to explore the long-term complications of EPLBD with endoscopic sphincterotomy (ES) in terms of cholangitis and biliary recurrence. Adult patients who underwent EPLBD with ES with complete bile duct clearance were included in the study. Primary outcome of the study was the rate of cholangitis; secondary outcome was biliary recurrence after EPLBD. RESULTS: 1221 patients with a median age of 77 years old (IQR 68-84) were included in the study. One hundred and forty-three patients (11.7%) experienced at least one episode of cholangitis with a cumulative 1-, 3-, and 5-year risk of cholangitis of 7.3%, 13.2%, and 15.3%, respectively. Cholangitis was caused by stones recurrence in 71.6% of cases, whereas alithiasic cholangitis was experienced in 22.9% of patients. The estimated 1-, 3-, and 5-year risk of biliary recurrence was 9.7%, 16.7%, and 21.8%, respectively. In multivariate cox regression analysis, ≥ 2 previous ERCPs before EPLBD were independently associated with increased risk of cholangitis and biliary recurrence. CONCLUSIONS: Cholangitis and biliary recurrence are not an infrequent complication after EPLBD. Biliary stone recurrence may be a consequence of SO dysfunction after EPLBD with ES; further comparative data are needed to evaluate whether EPLBD with ES is directly associated with long-term complications.