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Reconstruction of the Bile Duct With the Round Ligament

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03030573
Enrollment
20
Registered
2017-01-25
Start date
2015-11-30
Completion date
2018-11-30
Last updated
2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Obstruction, Extrahepatic

Keywords

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

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.

Interventions

PROCEDUREReconstruction 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.

Sponsors

Beaujon Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Safety - absence of any severe complication or mortality related to the new procedureat 1 yearSafety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.

Secondary

MeasureTime frameDescription
Bile buct patencyat 3 yearSecondary outcome include mainly the patency of the reconstructed bile duct.

Countries

France

Contacts

Primary ContactSafi Dokmak, MD
safi.dokmak@aphp.fr0033140875797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026