Treatment of Common Bile Duct Stones

Tongji Hospital

Status: Unknown

Conditions: Common Bile Duct Stone

Treatments: Procedure: LC + LCBDE + ENBD + primary closure of CBD; Procedure: LC + LCBDE + primary closure of CBD; Procedure: ERCP technique + LC

Study type: Interventional

Funder types: Other

Identifiers

NCT03442205

TJDBPS03

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with age between 18 - 80 years.
• Patients diagnosed with gallstones.
• Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
• Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
• Patients understood the trial and accepted one of the three managements.

Exclusion criteria

• Combined with Mirizzi syndrome and intrahepatic bile duct stones
• Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
• History of upper abdominal surgery.
• Serious heart, brain, lung, metabolic diseases history.
• Pregnant women.
• Unwillingness or inability to consent for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 3 patient groups

Group A

Experimental group

Treatment:

Procedure: LC + LCBDE + ENBD + primary closure of CBD

Group B

Experimental group

Treatment:

Procedure: ERCP technique + LC

Group C

Experimental group

Treatment:

Procedure: LC + LCBDE + primary closure of CBD