NCT03442205

Treatment of Common Bile Duct Stones

Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Common Bile Duct Stone

Interventions

Type	Name	Description
PROCEDURE	LC + LCBDE + ENBD + primary closure of CBD	LC + LCBDE + ENBD + primary closure of CBD
PROCEDURE	ERCP technique + LC	ERCP technique + LC
PROCEDURE	LC + LCBDE + primary closure of CBD	LC + LCBDE + primary closure of CBD

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-03-01
• Completion: 2021-03-01
• First posted: 2018-02-22
• Last updated: 2018-03-01

Locations

1 site across 1 country: China