Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-03-01
2021-03-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
LC + LCBDE + ENBD + primary closure of CBD
LC + LCBDE + ENBD + primary closure of CBD
Group B
ERCP technique + LC
ERCP technique + LC
Group C
LC + LCBDE + primary closure of CBD
LC + LCBDE + primary closure of CBD
Interventions
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LC + LCBDE + ENBD + primary closure of CBD
LC + LCBDE + ENBD + primary closure of CBD
ERCP technique + LC
ERCP technique + LC
LC + LCBDE + primary closure of CBD
LC + LCBDE + primary closure of CBD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Renyi Qin
Clinical professor
Principal Investigators
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Renyi Qin, pHD
Role: STUDY_CHAIR
Tongji Hospital
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TJDBPS03
Identifier Type: -
Identifier Source: org_study_id
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