Long-term Complications in Patients With Previous Endoscopic Papillary Large Balloon Dilation: a Nationwide Retrospective Study

Common bile duct stones are still the most common indication for endoscopic retrograde cholangiopancreatogrphy (ERCP). In the majority of cases bile duct clearance is obtained with standard techniques such as the execution of endoscopic sphincterotomy and the use of baskets and balloon catheters for bile duct stones extraction. In up to 10-15% of the cases, conventional techniques are unsuccessful defining the condition of difficult bile duct stones. The reason for a failed bile stones extraction is usually related to specific stone characteristics such as size, number, shape, consistency, location of the stone or certain biliary anatomy (biliary variants, altered anatomy intrahepatic locations of the stones, impacted stone). In these situations, the standard ERCP techniques for stones extraction could not be sufficient and advanced techniques are needed in order to obtain bile duct clearance. These includes endoscopic papillary large balloon dilation (EPLBD), mechanical lithotripsy and/or cholangioscopic-assisted lithotripsy. EPLBD is performed with a balloon catheter at the level of the papilla Balloon dilation allows a controlled dilation of the papilla and a subsequent extraction of the stones with the standard extraction devices. It demonstrated in different studies a high efficacy for difficult bile duct extraction compared to endoscopic sphincterotomy alone. EPLBD cause a complete disruption of the papilla orifice with a significant open communication between the duodenal lumen and the biliary tract. The absence of an anatomical barrier between the bile tract and the duodenal lumen could cause the translocation of intestinal bacteria and/or contamination with food particles with the potential risk of ascending cholangitis.

Aim of our study is to evaluate the natural history of patients who underwent to EPLBD especially focused on the appearance of cholangitis and bile duct stones relapse during a long-term follow-up (> 1 year). The primary objective is to evaluate the incidence of cholangitis episodes after EPLBD during a follow-up period of at least of 1 year. The secondary objective is to evaluate choledocholithiasis recurrence during a follow-up period of at least 1 year.