A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis.

INTRODUCTION: Outcomes after endoscopic sphincterotomy (ES) and subsequent laparoscopic cholecystectomy (LC) versus laparoscopic bile duct exploration (LBDE) during LC are comparable in fit patients with choledocholithiasis. This randomized, clinical trial aimed to determine the optimum treatment in patients with higher medical risk.

MATERIALS AND METHODS: Ninety-one higher risk patients with evidence of bile duct stones were randomized to ES/LC (group A) or LBDE during LC (group B). The primary outcome measure was duct clearance. Secondary outcome measures were complications, number of procedures per patient, conversion, and postoperative hospital stay (POS).

RESULTS: Forty-seven patients were randomized to ES/LC and 44 to LBDE. The median age was 74.56 years. On an intention-to-treat basis, duct clearance was achieved in 29 of 47 of group A and 44 of 44 of Group B patients (P < 0.001). Clavien Grade II-V complications occurred in 8 of 47 and 8 of 44 patients (P = 0.884), the median number of procedures was 2 (2-3) and 1 (1-1) (P < 0.001), 2 of 47 and 4 of 44 patients required conversion (P = 0.676), and the median POS was 3 (2-7) and 5 (2-7) days (P = 0.825), respectively.

CONCLUSIONS: There was no difference between approaches to duct clearance in terms of postoperative stay, complications, or conversion in higher risk patients, but the laparoscopic approach was more effective and efficient and avoided unnecessary procedures.