Long-term recurrence of bile duct stones after endoscopic papillary large balloon dilation with sphincterotomy: 4-year extended follow-up of a randomized trial.

Abstract

Endoscopic papillary large balloon dilation with biliary sphincterotomy (EPLBD+EBS) is safe and effective in patients with large common bile duct (CBD) stones. However, data on long-term outcomes after EPLBD+EBS remain limited. We sought to prospectively evaluate the long-term recurrence of CBD stones after EPLBD+EBS and to identify the associated factors. We conducted an extended follow-up of a previous randomized trial (2009-2011) comparing the outcomes of 30- versus 60-s large balloon dilation. A total of 106 trial participants undergoing successful CBD stone clearance by EPLBD+EBS were prospectively followed up for up to 4years (range 19-48months). Various risk factors were analysed to assess predictors of long-term recurrence of stones. Recurrent CBD stones appeared in 8/106 (7.5%) patients during a mean follow-up of 30.5±5.5months. The mean diameter of CBD was significantly higher in the recurrence versus non-recurrence group (2.0±4.9 vs 1.6±0.9cm, p=0.008). Multivariate analysis revealed that CBD diameter was the only predictor significantly associated with the long-term recurrence of stones (odds ratio 1.2, p=0.01). EPLBD+EBS is associated with a low rate of long-term CBD stone recurrence. However, the risk is significantly higher in patients with a more dilated CBD.