Reconstruction of the Bile Duct With the Round Ligament

Not Applicable

• Conditions: Bile Duct Obstruction, Extrahepatic
• Interventions: Procedure: Reconstruction of the bile duct with the round ligament

• Registration Number: NCT03030573
• Lead Sponsor: Beaujon Hospital

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-11-19
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-25
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-05
• Last Update Posted: 2017-02-07
• Primary Completion: 2017-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device: Round ligament and the bile duct	Reconstruction of the bile duct with the round ligament	The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.

Primary Outcome Measures

Name	Time	Method
Safety - absence of any severe complication or mortality related to the new procedure	at 1 year	Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.

Secondary Outcome Measures

Name	Time	Method
Bile buct patency	at 3 year	Secondary outcome include mainly the patency of the reconstructed bile duct.

Trial Locations

Locations (1)

Departement HPB surgery, Beaujon Hospital; 🇫🇷 Clichy, Hauts de seine, France