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Treatment of Common Bile Duct Stones

Primary Purpose

Common Bile Duct Stone

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LC + LCBDE + ENBD + primary closure of CBD
ERCP technique + LC
LC + LCBDE + primary closure of CBD
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Stone focused on measuring Common Bile Duct Stone;, Laparoscopic Common Bile Duct Exploration;, ERCP;

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Outcomes

Primary Outcome Measures

Rate of Adverse outcomes
The patients developing complications/ the total patients

Secondary Outcome Measures

Full Information

First Posted
February 17, 2018
Last Updated
February 28, 2018
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03442205
Brief Title
Treatment of Common Bile Duct Stones
Official Title
Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Stone
Keywords
Common Bile Duct Stone;, Laparoscopic Common Bile Duct Exploration;, ERCP;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
LC + LCBDE + ENBD + primary closure of CBD
Intervention Description
LC + LCBDE + ENBD + primary closure of CBD
Intervention Type
Procedure
Intervention Name(s)
ERCP technique + LC
Intervention Description
ERCP technique + LC
Intervention Type
Procedure
Intervention Name(s)
LC + LCBDE + primary closure of CBD
Intervention Description
LC + LCBDE + primary closure of CBD
Primary Outcome Measure Information:
Title
Rate of Adverse outcomes
Description
The patients developing complications/ the total patients
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Zhang, doctor
Phone
+8602783665314
Email
okashiiyo@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renyi Qin, pHD
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renyi Qin, pHD
Phone
+8602783665314
Email
ryqin@tjh.tjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Treatment of Common Bile Duct Stones

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