Comparative prospective randomized trial: laparoscopic versus open common bile duct exploration

Introduction: Single-stage laparoscopic procedures for common bile duct (CBD) stones are an alternative treatment option to two-stage endo-laparoscopic treatment and to open choledocholithotomy. Several reports have demonstrated the feasibility, safety, efficiency and cost-effectiveness of laparoscopic techniques. Aim: To analyse the safety and benefits of laparoscopic compared to open common bile duct (CBD) exploration. Material and methods: The prospective randomized trial included a total of 256 patients with CBD stones operated from 2005 to 2009 in a single centre. The male/female ratio was 82/174, with a median age 62.3 +/- 5.8 years (range 27 to 87 years). There were two groups of patients. Group laparoscopic CBD exploration (138 patients). Group open CBD exploration (118 patients). Patient comorbidity was assessed by means of the American Society of Anesthesiologists (ASA) classification; ASA II - 109 patients, ASA III - 59 patients. Bile duct stones were visualized preoperatively by means of US examination in 129 patients, by means of ERCP in 26 patients, and by magnetic resonance cholangiopancreatography (MRCP) in 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography. Results: The mean duration of laparoscopic procedures was 82 min (range 40-160 min). The mean duration of open procedures was 90 min (range 60-150 min). Mean blood loss was much lower in the laparoscopic group than in the open group (20 +/- 2 vs 285 +/- 27), p < 0.01. Postoperative complications were observed in 7 patients of the laparoscopic group and in 15 patients in the open group (p < 0.01). Laparoscopic common bile duct exploration was performed through a trans-cystic approach in 76 patients and via choledochotomy in 62 patients. The transcystic approach was successful in 76 patients (74.5%). External drainage was used in 25 (32.8%) patients with the transcystic approach. Conclusions: Laparoscopic CBD exploration can be performed with high efficiency, and minimal morbidity and mortality Laparoscopic procedures have advantages over open ones in terms of postoperative morbidity and length of hospital stay.