Reconstruction of the Bile Duct With the Round Ligament

Bile Duct Obstruction, Extrahepatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03030573
• Other study ID #: Beaujon Hospital
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2016
• Last updated: February 5, 2017
• Start date: November 2015
• Est. completion date: November 2018

Study information

• Verified date: February 2017
• Source: Beaujon Hospital
• Contact: Safi Dokmak, MD
• Phone: 0033140875797
• Email: safi.dokmak[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Obstruction, Extrahepatic
• Cholestasis
• Cholestasis, Extrahepatic

Intervention

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.

Locations

Country	Name	City	State
France	Departement HPB surgery, Beaujon Hospital	Clichy	Hauts de seine

Sponsors (1)

Lead Sponsor	Collaborator
Beaujon Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 1 year
Secondary	Bile buct patency	Secondary outcome include mainly the patency of the reconstructed bile duct.	at 3 year