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Background: Laparoscopic common bile duct exploration (LCBDE) has gained wide popularity for the treatment of choledocholithiasis. However, it remains unclear whether LCBDE is a better alternative option for the patients with difficult biliary stones. Thus, the aim of the present study was to explore the safety and efficacy of LCBDE for these patients by retrospectively analyzing our data and combing with literature review. Methods: Between September 2011 and February 2019, 1064 consecutive patients who underwent LCBDE at Shanghai Tenth People’s Hospital were reviewed. The clinical data of patients with difficult biliary stones were selected and retrospectively analyzed. Results: Of these patients, 334 cases were confirmed with difficult biliary stones, and the overall complete stone clearance rate was 98.8% (330/334). 34 cases (10.2%) were performed with laser lithotripsy. A total of 296 patients (88.6%) underwent primary closure of common bile duct, and T-tube drainage was indwelled in 38 patients (11.4%). No bile duct injury, bleeding, perforation and surgery-related deaths were observed. The overall morbidity rate was 6.6%. 16 cases (4.8%) occurred in bile leakage with primary closure procedure, and all of them were managed successfully with conservative therapy. The median follow-up period was 9 months with stone recurrence occurring in 9 patients (2.7%). There was no evidence of bile duct stricture in all cases. Conclusions: The current study suggests that LCBED is a considerable safe and effective option for the patients with difficult biliary stones. A randomized clinical trial is needed to further evaluate the benefit of LCBDE in this subgroup.

Laparoscopic common bile duct exploration (LCBDE) has gained wide popularity in the treatment of choledocholithiasis. Bile leakage remains a major cause of postoperative morbidity. The aim of this study was to report 5-year results of 500 LCBDEs and identify risk factors associated with bile leakage. Five hundred consecutive LCBDEs performed in one institution from September 2011 to June 2016 were reviewed. Patients’ clinical data were retrospectively collected and analyzed. Univariable and multivariable analysis of bile leakage was performed by logistic regression. We found stones (n= 388) or bile sludge (n= 71) in 459 patients (92%) on exploration, leaving 41 patients (8%) without stones. Operative time was 128 min in the first 250 LCBDEs, and this decreased to 103 min in the second 250 LCBDEs (P= 0.0004). Four hundred and eight (82%) procedures were completed with primary closure after choledochotomy; the rate of primary closure increased significantly in the second 250 patients compared with the first (88 vs 76%; P= 0.0005), whereas T-tube placement (2 vs 6%; P= 0.0225) and transcystic approach (7 vs 12%; P= 0.0464) decreased, respectively. Stone clearance was successful in 495 patients (99%). Overall morbidity was 5%, and bile leakage occurred in 17 patients (3.4%). Two patients died from bile leakage. The median follow-up was 24 months with stone recurrence occurred in two patients and bile duct stricture in one patient. Univariable analysis identified diameter of the common bile duct (CBD), stone clearance, and T-tube insertion as risk factors related to bile leakage. Multivariable analysis taking these three factors into account identified non-dilated CBD (risk ratio (RR) = 9.87; P= 0.007) and failure in stone clearance (RR = 11.88; P= 0.024) as significant risk factors. Bile leakage following LCBDE is associated with diameter of the CBD and stone clearance. LCBDE would be safer in proficient laparoscopic surgeons with a careful selection of patients.