Endoscopic papillary balloon dilation after sphincterotomy for difficult choledocholithiasis: A case-controlled study

摘要

AIM: To evaluate the efficacy and safety of endoscopic sphincterotomy (EST) + endoscopic papillary large balloon dilation (EPLBD) vs isolated EST.METHODS: We conducted a retrospective single center study over two years, from February 2010 to January 2012. Patients with large (≥ 10 mm), single or multiple bile duct stones (BDS), submitted to endoscopic retrograde cholangio-pancreatography (ERCP) were included. Patients in Group A underwent papillary large balloon dilation after limited sphincterotomy (EST+EPLBD), using a through-the-scope balloon catheter gradually inflated to 12-18 mm according to the size of the largest stone and the maximal diameter of the distal bile duct on the cholangiogram. Patients in Group B (control group) underwent isolated sphincterotomy. Stones were removed using a retrieval balloon catheter and/or a dormia basket. When necessary, mechanical lithotripsy was performed. Complete clearance of the bile duct was documented with a balloon catheter cholangiogram at the end of the procedure. In case of residual lithiasis, a double pigtail plastic stent was placed and a second ERCP was planned within 4-6 wk. Some patients were sent for extracorporeal lithotripsy prior to subsequent ERCP. Outcomes of EST+EPLBD (Group A) vs isolated EST (Group B) were compared regarding efficacy (complete stone clearance, number of therapeutic sessions, mechanical and/or extracorporeal lithotripsy, biliary stent placement) and safety (frequency, type and grade of complications). Statistical analysis was performed using χ² or Fisher’s exact tests for the analysis of categorical parameters and Student’s t test for continuous variables. A P-value of less than 0.05 was considered statistically significant.RESULTS: One hundred and eleven patients were included, 68 (61.3%) in Group A and 43 (38.7%) in Group B. The mean diameter of the stones was similar in the two groups (16.8 ± 4.4 and 16.0 ± 6.7 in Groups A and B, respectively). Forty-eight (70.6%) patients in Group A and 21 (48.8%) in Group B had multiple BDS (P = 0.005). Overall, balloon dilation was performed up to 12 mm in 10 (14.7%) patients, 13.5 mm in 17 (25.0%), 15 mm in 33 (48.6%), 16.5 mm in 2 (2.9%) and 18 mm in 6 (8.8%) patients, taking into account the diameter of the largest stone and that of the bile duct. Complete stone clearance was achieved in sixty-five (95.6%) patients in Group A vs 30 (69.8%) patients in Group B, and was attained within the first therapeutic session in 82.4% of patients in Group A vs 44.2% in Group B (P < 0.001). Patients submitted to EST+EPLBD underwent fewer therapeutic sessions (1.1 ± 0.3 vs 1.8 ± 1.1, P < 0.001), and fewer required mechanical (14.7% vs 37.2%, P = 0.007) or extracorporeal (0 vs 18.6%, P < 0.001) lithotripsy, as well as biliary stenting (17.6% vs 60.5%, P < 0.001). The rate of complications was not significantly different between the two groups.CONCLUSION: EST+EPLBD is a safe and effective technique for treatment of difficult BDS, leading to high rates of complete stone clearance and reducing the need for lithotripsy and biliary stenting.