Published online Dec 28, 2017. doi: 10.3748/wjg.v23.i48.8597
Peer-review started: August 15, 2017
First decision: August 29, 2017
Revised: October 31, 2017
Accepted: November 14, 2017
Article in press: November 14, 2017
Published online: December 28, 2017
To describe the efficacy and safety of endoscopic papillary large balloon dilatation (EPLBD) in the management of bile duct stones in a Western population.
Data was collected from the endoscopic retrograde cholangiopancreatography (ERCP) and Radiology electronic database along with a review of case notes over a period of six years from 1st August 2009 to 31st July 2015 and incorporated into Microsoft excel. Statistical analyses were performed using MedCalc for Windows, version 12.5 (MedCalc Software, Ostend, Belgium). Simple statistical applications were applied in order to determine whether significant differences exist in comparison groups. We initially used simple proportions to describe the study populations. Furthermore, we used chi-square test to compare proportions and categorical variables. Non-parametric Mann-Whitney U-test was applied in order to compare continuous variables. All comparisons were deemed to be statistically significant if P values were less than 0.05.
EPLBD was performed in 229 patients (46 females) with mean age of 68 ± 14.3 years. 115/229 (50%) patients had failed duct clearance at previous ERCP referred from elsewhere with standard techniques. Duct clearance at the Index* ERCP (1st ERCP at our centre) was 72.5%. Final duct clearance rate was 98%. EPLBD after fresh sphincterotomy was performed in 81 (35.4%). Median balloon size was 13.5 mm (10 - 18). In addition to EPLBD, per-oral cholangioscopy (POC) and electrohydraulic lithotripsy (EHL) was performed in 35 (15%) patients at index* ERCP. 63 (27.5%) required repeat ERCP for stone clearance. 28 (44.5%) required POC and EHL and 11 (17.4%) had repeat EPLBD for complete duct clearance. Larger stone size (12.4 mm vs 17.4 mm, P < 0.000001), multiple stones (2, range (1-13) vs 3, range (1-12), P < 0.006) and dilated common bile duct (CBD) (12.4 mm vs 18.3 mm, P < 0.001) were significant predictors of failed duct clearance at index ERCP. 47 patients (20%) had ampullary or peri-ampullary diverticula. Procedure related adverse events included 2 cases of bleeding and pancreatitis (0.87%) each.
EPLBD is a safe and effective technique for CBDS removal. There is no difference in outcomes whether it is performed at the time of sphincterotomy or at a later procedure or whether there is a full or limited sphincterotomy.
Core tip: This is one of the largest published series describing the management of difficult biliary stone disease utilizing large balloon sphincteroplasty in a Western population. Our findings suggest that large balloon sphincteroplasty can be performed and repeated safely and effectively in those with a sphincterotomy irrespective of its timing and size to establish complete duct clearance.