Common Bile Duct Stone Clinical Trial
Official title:
Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones
ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation,
especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for
treatment. This study compares outcomes of different surgical procedures treating for the
disease.
Methods/design: This is a prospective, randomized, controlled multicenter trial with three
treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD
exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure
of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography
(ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) +
laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire
trial is two years including prearrangement, follow-up and analyses.
Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these
approaches would appear comparable. It is hopeful to fully address which would be the better
approach with this RCT design.
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