Reconstruction of the Bile Duct With the Round Ligament
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|ClinicalTrials.gov Identifier: NCT03030573|
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : February 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bile Duct Obstruction, Extrahepatic||Procedure: Reconstruction of the bile duct with the round ligament||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Bile buct patency [ Time Frame: at 3 year ]Secondary outcome include mainly the patency of the reconstructed bile duct.
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
|Contact: Safi Dokmak, MDemail@example.com|
|Departement HPB surgery, Beaujon Hospital||Recruiting|
|Clichy, Hauts de seine, France, 92110|
|Contact: Safi Dokmak, MD 0033140875797 firstname.lastname@example.org|
|Principal Investigator: Safi Dokmak, MD|
|Principal Investigator:||Safi Dokmak, MD||HBP department, Beaujon hospital, Clichy, France|