Treatment of Common Bile Duct Stones

Common Bile Duct Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03442205
• Other study ID #: TJDBPS03
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2018
• Last updated: February 28, 2018
• Start date: March 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2018
• Source: Tongji Hospital
• Contact: Hang Zhang, doctor
• Phone: +8602783665314
• Email: okashiiyo[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Common Bile Duct Stone
• Gallstones

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

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