Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct

September 26, 2016 updated by: Dajiang li, Southwest Hospital, China
This study evaluates the clinical application of cholangiojejunostomy in the surgical treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the other half will receive hepatectomy and T-tube Drainage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hepatic bile duct stone disease, need surgery
  • No residual stones in the operation
  • Extrahepatic bile duct dilatation, 15-30 mm in diam.
  • No relaxation or stenosis of the sphincter of Oddi

Exclusion Criteria:

  • Patient involuntary
  • Surgical treatment can not be performed because of various reasons.
  • Intrahepatic and extrahepatic bile duct stones can not be taken away
  • with other biliary tract diseases, such as bile duct cancer
  • Oddi sphincter relaxation or stenosis
  • loss to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: participants receive cholangiojejunostomy
participants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage
Procedure: cholangiojejunostomy
Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage,while the other half will receive hepatectomy and T-tube Drainage
Procedure: hepatectomy
Device: T-tube
T-tube Drainage
ACTIVE_COMPARATOR: participants receive no cholangiojejunostomy
participants will receive hepatectomy and T-tube Drainage
Procedure: hepatectomy
Device: T-tube
T-tube Drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of bile duct stones
Time Frame: 2-3 years
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (ESTIMATE)

September 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014（18）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholelithiasis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe