NCT03442205

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 17, 2018

Last Update Submit

February 28, 2018

Conditions

Common Bile Duct Stone

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Rate of Adverse outcomes

    The patients developing complications/ the total patients

    24 months

Study Arms (3)

Group A

EXPERIMENTAL
Procedure: LC + LCBDE + ENBD + primary closure of CBD

Group B

EXPERIMENTAL
Procedure: ERCP technique + LC

Group C

EXPERIMENTAL
Procedure: LC + LCBDE + primary closure of CBD

Interventions

LC + LCBDE + ENBD + primary closure of CBDPROCEDURE

LC + LCBDE + ENBD + primary closure of CBD

Group A
ERCP technique + LCPROCEDURE

ERCP technique + LC

Group B
LC + LCBDE + primary closure of CBDPROCEDURE

LC + LCBDE + primary closure of CBD

Group C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Renyi Qin, pHD

    Tongji Hospital

    STUDY CHAIR

Central Study Contacts

Hang Zhang, doctor

CONTACT

+8602783665314okashiiyo@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

February 17, 2018

First Posted

February 22, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2021

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)