ClinicalTrials.gov
ClinicalTrials.gov Menu

Reconstruction of the Bile Duct With the Round Ligament

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03030573
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Safi Dokmak, Beaujon Hospital

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

Condition or disease Intervention/treatment Phase
Bile Duct Obstruction, Extrahepatic Procedure: Reconstruction of the bile duct with the round ligament Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Device: Round ligament and the bile duct
The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.
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.




Primary Outcome Measures :
  1. Safety - absence of any severe complication or mortality related to the new procedure [ Time Frame: 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 :
  1. Bile buct patency [ Time Frame: at 3 year ]
    Secondary outcome include mainly the patency of the reconstructed bile duct.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030573


Contacts
Contact: Safi Dokmak, MD 0033140875797 safi.dokmak@aphp.fr

Locations
France
Departement HPB surgery, Beaujon Hospital Recruiting
Clichy, Hauts de seine, France, 92110
Contact: Safi Dokmak, MD    0033140875797    safi.dokmak@bjn.aphp.fr   
Principal Investigator: Safi Dokmak, MD         
Sponsors and Collaborators
Beaujon Hospital
Investigators
Principal Investigator: Safi Dokmak, MD HBP department, Beaujon hospital, Clichy, France

Responsible Party: Safi Dokmak, MD, Beaujon Hospital
ClinicalTrials.gov Identifier: NCT03030573     History of Changes
Other Study ID Numbers: Beaujon Hospital
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Safi Dokmak, Beaujon Hospital:
Bile duct injury
Bile duct defect
Round ligament
Reconstruction

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Extrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases