A prospective randomized trial comparing two-stage versus single-stage management of patients with gallstone disease and common bile duct stones.

BACKGROUND: The optimal management of patients with concomitant common bile duct stones and gallstones is still evolving. With the introduction of laparoscopic common bile duct exploration, many centers prefer single-stage laparoscopic cholecystectomy and common bile duct exploration over preoperative endoscopic bile duct clearance followed by laparoscopic cholecystectomy. The present study was done to compare these two management options. PATIENTS AND METHODS: 30 patients with symptomatic gallstones and common bile duct stones were randomized to either treatment option. Preoperative endoscopic ultrasound (EUS) and/or magnetic resonance pancreaticography (MRCP) was done in all patients to confirm the diagnosis. In group I, laparoscopic cholecystectomy and common bile duct exploration was done at the same sitting; in group II, endoscopic stone clearance was followed by laparoscopic cholecystectomy 4-6 weeks later. Success was defined as successful treatment by the intended modality.
RESULTS: 15 patients were randomized to each group and the two groups had comparable demographic and clinical profile. In group I there was a success rate of 93.5% in comparison with 86.7% in group II (p = 0.32, Fisher's exact test). The complications were similar in the two groups.
CONCLUSIONS: The results showed equivalent success rate in terms of morbidity and hospital stay. Laparoscopic approach seems to be favorable because of the smaller number of procedures and hospital visits.

RCT Entities:   Population Interventions Outcomes