Small endoscopic sphincterotomy plus large balloon dilatation for common bile duct stones larger than 12mm： a randomized comparative study with endoscopic sphincterotomy

Objective To evaluate the efficacy and safety of small endoscopic sphincterotomy （EST） plus large balloon dilataion （EPLBD） for removal of common bile duct （CBD） stones larger than 12mm. Methods From June 2009 to December 2011, a total of 198 patients with CBD stones were randomly divided into two groups to receive EPLBD （ n = 100） or EST only （ n = 98 ）. The rate of complete stone removal after the first session, the overall success rate of stone removal, the rate of using mechanical lithotripsy （ ML）, the rate of post procedure complication, procedure time and fluoroscopy time were compared between the two groups. Results The rate of complete stone removal after the first session in EPLBD group （89.0%） was significantly higher than that in EST group （71.4%, P 〈0. 05）. ML was required significantly more often in EST group （35.7%） compared to EPLBD group （ 12. 0%, P 〈0. 05）. Total procedure time and total fluoroscopy time in EPLBD group （39.3 ± 15.8 min and 14. 2 ±5.2 min） were significantly shorter than those of EST group （48.4 ± 19.3 min and 24. 2 ± 9.4 min, P 〈 0. 05 ）. There was no significant difference between two groups in overall success rate of stone removal （97.0% in EPLBD vs. 93.9% in EST group, P 〉0.05） and the complications rate （8.0% in EPLBD vs. 13.3% in ESTgroup, P 〉 0. 05）. Conclusion EPLBD is as safe and effective as EST for common bile duct stones, larger than 12mm, and is more efficient in terms of procedure time, use of ML and success rate of stone removal. Key words: Choledocholithiasis ;  Sphincterotomy, endoscopic ;  Endoscopic papillary balloon dilation