Long-term complications in patients with previous endoscopic papillary large balloon dilation: a nationwide retrospective study

Aims Difficult bile stones (DBS) accounts for 10 to 15% of choledocholithiasis cases. In this setting different endoscopic techniques are available to obtain bile duct clearance. Of them endoscopic papillary large balloon dilation (EPLBD) demonstrated high rate of efficacy and is usually performed as a first step when DBS are encountered. However, EPLBD cause a complete disruption of the papilla orifice with a significant open communication between the duodenal lumen and the biliary tract, potentially exposing patients to cholangitis. To date, no data are available to the long-term consequence of EPLBD.

Methods This is a multicenter retrospective study conducted within 16 centers of the i-EUS network. It were included in the study adult patients who underwent to EPLBD (balloon diameter≥10 mm) and obtained complete bile duct clearance in one or more endoscopic sessions from January 2017 with at least 6 months of follow-up. Patients with surgical altered anatomy and those with orthotopic liver transplantation were excluded. Primary outcome of the study was the rate of cholangitis; secondary outcome was endoscopic reintervention after EPLBD.

Results 420 patients (215 female) with a median age of 78 yo (IQR 70-85) were included in the study. EPLBD was performed after previous failed ERCP standard treatments in 54% of cases. Indication for EPLBD was a single large or multiple stones with a median diameter of 14 mm (IQR 10-16). Large balloon dilation was performed at a median diameter of 12 mm (IQR 12-15) and complete bile duct clearance was obtained with a mean of 1.2 (SD 0.49) procedures that was assessed in 95.8% of cases with cholangiography and in the remaining of cases with cholangioscopy or cross-sectional imaging. Intra-procedural or short-term adverse events (AEs) were recorded in 9.1% of patients (of them 78% bleeding and 22% perforation). During a median follow-up time of 2.1 years (IQR 1.4-3.3) 45 patients (10.7%) experienced at least one episode of cholangitis that have occurred after a median time of 316 days from EPLBD (IQR 147-456 days). Cholangitis was caused by stones recurrence in 80% of cases whereas in the remaining 20% was related to ascending cholangitis. Cholangitis was managed in the majority of cases (88.8%) with ERCP and in the remaining with conservative antibiotic therapy. No deaths were related to these episodes but in 10% of cases admission in intensive care unit was required. Globally 14.7% of patients required at least one ERCP reintervention during the follow-up [1].

Conclusions Preliminary results of this long-term follow-up study showed that cholangitis and endoscopic reinterventions are not so uncommon in patients who underwent to EPLBD. These complications should be taken into account and patients need surveillance after EPLBD in order to avoid sudden hospitalizations.

Publication History

Article published online:
27 March 2025

• References

• 1 Kogure H. Endoscopy 2020; 52 (09): 736-744