Reconstruction of the Bile Duct With the Round Ligament

NCT ID: NCT03030573

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Bile Duct Obstruction, Extrahepatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device: Round ligament and the bile duct

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Group Type OTHER

Reconstruction of the bile duct with the round ligament

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beaujon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Safi Dokmak

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Safi Dokmak, MD

Role: PRINCIPAL_INVESTIGATOR

HBP department, Beaujon hospital, Clichy, France

Locations

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Departement HPB surgery, Beaujon Hospital

Clichy, Hauts de seine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Safi Dokmak, MD

Role: CONTACT

0033140875797

Facility Contacts

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Safi Dokmak, MD

Role: primary

0033140875797

Other Identifiers

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Beaujon Hospital

Identifier Type: -

Identifier Source: org_study_id

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