Complex biliary stones management: cholangioscopy versus papillary large balloon dilation – a randomized controlled trial

Abstract

Background and study aims Endoscopic removal of biliary stones has high success rates, ranging between 85 % to 95 %. Nevertheless, some stones may be challenging and different endoscopic methods have evolved. Papillary large balloon dilation after sphincterotomy is a widely used technique with success rates ranging from 68 to 90 % for stones larger than 15 mm. Cholangioscopy allows performing lithotripsy under direct biliary visualization, either by laser or electrohydraulic waves, which have similar success rate (80 % – 90 %). However, there is no study comparing these 2 techniques. Patients and methods From April 2014 to June 2016, 100 patients were enrolled and randomized in 2 groups, using a non-inferiority hypothesis: cholangioscopy + electrohydraulic lithotripsy (group 1) and endoscopic papillary large balloon dilation (group 2). The main outcome was complete stone removal. Adverse events were documented. Mechanical lithotripsy was not performed. Failure cases had a second session with crossover of the methods. Results The mean age was 56 years. 74 (75.5 %) patients were female. The initial overall complete stone removal rate was 74.5 % (77.1 % in group 1 and 72 % in group 2, P > 0.05). After second session the overall success rate achieved 90.1 %. Procedure time was significantly lower in group 2, – 25.2 min (CI95 % – 12.48 to – 37.91). There were no significant differences regarding technical success rate, radiologic exposure and adverse events. Conclusion Single-operator cholangioscopy-guided lithotripsy and papillary large balloon dilation are effective and safe approaches for removing complex biliary stones.

Single‐operator peroral cholangioscope in treating difficult biliary stones: A systematic review and meta‐analysis

“…Baseline characteristics of the studies are presented in Table . Fourteen studies reported procedure duration . Median duration was 68.7 min, ranging from 30 min to 165 min.…”

“…Figure 1 shows the PRISMA flow diagram of selected studies. Of the 24 studies evaluated, 13 were carried out in America, 12,14,15,[17][18][19]21,22,25,26,30,31,35 seven in Asia, 13,20,23,24,27,29,34 three in Europe, 16,28,33 and one was a multinational study spanning America, Asia, and Europe. 32 Ten studies were multicenter.…”

“…32 Ten studies were multicenter. 12,14,16,19,22,23,25,30,32,33 Two studies were randomized controlled trials (RCT), 26,35 and the remaining 22 were cohort studies. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][27][28][29][30][31][32][33][34] Seven of the cohort studies were prospective, [13][14][15]23,[27][28][29] and the remaining 15 were retrospective.…”

Biliary interventions using single‐operator cholangioscopy

“…While SOC appears to be efficacious for the treatment of large bile duct stones, their precise role in the treatment algorithm is unclear. In a randomized controlled trial (RCT) comparing SOC with EHL and endoscopic papillary large‐balloon dilation, 100 patients with difficult bile duct stones were randomized . The main outcome was complete stone removal.…”

“…There was no difference in the overall complete stone removal rate, technical success rate, radiologic exposure and adverse events. Procedure time was significantly lower with the use of endoscopic papillary large‐balloon dilation compared to SOC with EHL . In another RCT from our institution comparing D‐SOC with LL and endoscopic papillary large‐balloon dilation, 66 patients were randomized.…”