Comparison of endoscopic papillary large balloon dilation with or without endoscopic sphincterotomy for the treatment of large bile duct stones

Abstract

Background Endoscopic papillary large balloon dilation (EPLBD) without prior endoscopic sphincterotomy (EST) produces excellent outcomes for the treatment of large common bile duct (CBD) stones. However, it remains unclear how the outcomes of EPLBD alone compare with those of EPLBD with EST. In this study, we assessed the safety and therapeutic outcomes of EPLBD with vs. without EST for the removal of large bile duct stones. Methods This prospective, multicenter study was conducted on 200 patients with bile duct stones of ≥ 10 mm in diameter. Patients were randomly assigned to an EPLBD alone group (n = 100) or an EPLBD with EST group (n = 100). These two groups were compared with respect to overall procedure-related adverse events, overall stone removal success rate, number of endoscopic sessions required for complete stone removal, need for mechanical lithotripsy, and total procedure time. Results The incidence of adverse events was not significantly different between the groups (EPLBD alone vs. EPLBD with EST: overall adverse events 6 % vs. 4 %, P = 0.75; pancreatitis 1 % vs. 3 %, P = 0.62). Overall success (P = 0.35), initial success (P = 0.28), and the need for mechanical lithotripsy (P = 0.39) were also similar between groups. Median total procedure time tended to be greater in the EPLBD alone group (20.5 minutes) than in the EPLBD with EST group (18 minutes; P = 0.08). Conclusion The therapeutic outcomes and adverse events of EPLBD alone for the removal of large bile duct stones were comparable to those of EPLBD with EST.

Gallensteinerkrankungen

“…Dies ist vor allem für die Entwicklung von Steinrezidiven, die sich bei Patienten mit Steinextraktion nach Bal-londilatation beinahe halbiert, signifikant. Bei der kombinierten Behandlung von Gallengangsteinen > 10 mm mit Ballondilatation nach vorheriger EPT zeigte sich: Bei vergleichbarer Erfolgsrate waren sowohl das Pankreatitis-Risiko als auch die Blutungsrate im Vergleich zur alleinigen EPT nicht erhöht [55,56].…”

Balloons larger than 15 mm can increase the risk of adverse events following endoscopic papillary large balloon dilation

“…It was believed that an EST before EPLBD may prevent post‐procedural pancreatitis because the radial force produced by balloon dilation is shifting along the EST direction rather than pancreatic duct direction . However, many studies have reported that EPLBD without a preceding EST is as effective and safe for difficult bile duct stone removal without increasing the risk of pancreatitis …”

“…6,7 However, many studies have reported that EPLBD without a preceding EST is as effective and safe for difficult bile duct stone removal without increasing the risk of pancreatitis. 8,9 In early EPLBD trials, the balloon dilation of the biliary orifice was extended up to a diameter of 20 mm, whereas today, balloons with diameters > 15 mm tend to be less frequently used than in the earlier days because of concerns about potential perforations or bleeding. However, there has been limited data regarding the frequency of severe-to-fatal adverse events during EPLBD using larger balloons (> 15 mm).…”

Endoscopic papillary large balloon dilation: more questions than answers

“…The design of the RCT by Kogure et al did not intend to compare EPLBD with or without the use of EST. In this journal last year, Park et al [5] randomized 200 patients with bile duct stones > 10 mm in size to receive EPLBD alone or EPLBD with EST. The overall adverse event rates were low (6 vs. 4 %) and the pancreatitis rates were 1 % vs. 3 %, respectively.…”