Treatment of Common Bile Duct Stones

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03442205

Enrollment

200

Registered

2018-02-22

Start date

2018-03-01

Completion date

2021-03-01

Last updated

2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct Stone

Keywords

Common Bile Duct Stone;, Laparoscopic Common Bile Duct Exploration;, ERCP;

Brief 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.

Interventions

PROCEDURELC + LCBDE + ENBD + primary closure of CBD

LC + LCBDE + ENBD + primary closure of CBD

PROCEDUREERCP technique + LC

ERCP technique + LC

PROCEDURELC + LCBDE + primary closure of CBD

LC + LCBDE + primary closure of CBD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of Adverse outcomes	24 months	The patients developing complications/ the total patients

Countries

China

Contacts

Primary ContactHang Zhang, doctor

okashiiyo@126.com+8602783665314

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026