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Reconstruction of the Bile Duct With the Round Ligament

Primary Purpose

Bile Duct Obstruction, Extrahepatic

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Reconstruction of the bile duct with the round ligament

About this trial

This is an interventional treatment trial for Bile Duct Obstruction, Extrahepatic focused on measuring Bile duct injury, Bile duct defect, Round ligament, Reconstruction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

1) The absence of the round ligament

Sites / Locations

Departement HPB surgery, Beaujon HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Device: Round ligament and the bile duct

Arm Description

The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.

Outcomes

Primary Outcome Measures

Safety - absence of any severe complication or mortality related to the new procedure

Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.

Secondary Outcome Measures

Bile buct patency

Secondary outcome include mainly the patency of the reconstructed bile duct.

Full Information

NCT ID

NCT03030573

First Posted

November 19, 2016

Last Updated

February 5, 2017

Sponsor

Beaujon Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03030573

Brief Title

Reconstruction of the Bile Duct With the Round Ligament

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beaujon Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bile Duct Obstruction, Extrahepatic

Keywords

Bile duct injury, Bile duct defect, Round ligament, Reconstruction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Device: Round ligament and the bile duct

Arm Type

Other

Arm Description

The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.

Intervention Type

Procedure

Intervention Name(s)

Reconstruction of the bile duct with the round ligament

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety - absence of any severe complication or mortality related to the new procedure

Description

Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.

Time Frame

at 1 year

Secondary Outcome Measure Information:

Title

Bile buct patency

Description

Secondary outcome include mainly the patency of the reconstructed bile duct.

Time Frame

at 3 year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Radiological or operative diagnosis of bile duct Injury or defect Can underwent surgical procedure Exclusion Criteria: 1) The absence of the round ligament

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Safi Dokmak, MD

Phone

0033140875797

safi.dokmak@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Safi Dokmak, MD

Organizational Affiliation

HBP department, Beaujon hospital, Clichy, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Departement HPB surgery, Beaujon Hospital

City

Clichy

State/Province

Hauts de seine

ZIP/Postal Code

92110

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Safi Dokmak, MD

Phone

0033140875797

safi.dokmak@bjn.aphp.fr

First Name & Middle Initial & Last Name & Degree

Safi Dokmak, MD

12. IPD Sharing Statement

Plan to Share IPD

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Reconstruction of the Bile Duct With the Round Ligament

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