Treatment of Common Bile Duct Stones

T

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

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

Trial contacts and locations

1

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Central trial contact

Hang Zhang, doctor

Data sourced from clinicaltrials.gov

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