Reconstruction of the Bile Duct With the Round Ligament

February 5, 2017 updated by: Safi Dokmak, Beaujon Hospital

Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament

The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

  • France
    • Hauts de seine
      • Clichy, Hauts de seine, France, 92110
        • Recruiting
        • Departement HPB surgery, Beaujon Hospital
        • Contact:
        • Principal Investigator:
          • Safi Dokmak, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Radiological or operative diagnosis of bile duct Injury or defect
  2. Can underwent surgical procedure

Exclusion Criteria:

1) The absence of the round ligament

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Device: Round ligament and the bile duct
The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.
Procedure: Reconstruction of the bile duct with the round ligament
In patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - absence of any severe complication or mortality related to the new procedure
Time Frame: at 1 year
Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.
at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bile buct patency
Time Frame: at 3 year
Secondary outcome include mainly the patency of the reconstructed bile duct.
at 3 year

Collaborators and Investigators

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

Sponsor

Beaujon Hospital

Investigators

  • Principal Investigator: Safi Dokmak, MD, HBP department, Beaujon hospital, Clichy, France

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

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

November 19, 2016

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 5, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beaujon Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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