Treatment of Common Bile Duct Stones

Study Overview
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Brief Summary
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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.

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

Conditions
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Common Bile Duct Stone

Intervention / Treatment
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* Procedure: LC + LCBDE + ENBD + primary closure of CBD
* Procedure: ERCP technique + LC
* Procedure: LC + LCBDE + primary closure of CBD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Procedure: LC + LCBDE + ENBD + primary closure of CBD<br>* LC + LCBDE + ENBD + primary closure of CBD<br>|
| Experimental: Group B<br> | Procedure: ERCP technique + LC<br>* ERCP technique + LC<br>|
| Experimental: Group C<br> | Procedure: LC + LCBDE + primary closure of CBD<br>* LC + LCBDE + primary closure of CBD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adverse outcomes | The patients developing complications/ the total patients | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common Bile Duct Stone;, Laparoscopic Common Bile Duct Exploration;, ERCP;