Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.
NCT ID: NCT03993067
Last Updated: 2021-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2018-11-15
2020-01-15
Brief Summary
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Detailed Description
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Objective: this study aimed to assess the clinical validation of Hemopatch to prevent post-operative biliary fistula. Secondarily, it is aimed to evaluate the clinical validity of the two proposed definition of biliary fistula.
Methods: According to the incidence of BF in our previous series (considering ISGLS definition), we designed a randomized controlled study on 220 patients, who underwent hepatic resection from 2018 to 2020. Patients were randomized to treatment group A (Hemopatch) and standard group B (Tisseal and Tabotamp). Both ISGLS and HRH definitions of BF were considered. All patients were systematically drained. Drains were maintained at least 5 days, and bilirubin was measured on PODs 3, 5, and 7. Drains were removed if the bilirubin concentration in the drain fluid was less than 10 mg/dL on POD 7. A statistical analysis to compare perioperative variables between two groups was performed. Then, a multivariate analysis was performed to identify potential risk factors for BF.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard Treatment
Fibrin glue and Tabotamp on cut surface
Fribrin glue and Tabotamp
Fibrin glue and Tabotampis the standard treatment
Hemopatch
Hemopatch on cut surface
Hemopatch
Hemopatch is a collagen based sealant is a hemostat agent. We want to investigate his role in the prevention of post operative biliary fistula
Interventions
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Hemopatch
Hemopatch is a collagen based sealant is a hemostat agent. We want to investigate his role in the prevention of post operative biliary fistula
Fribrin glue and Tabotamp
Fibrin glue and Tabotampis the standard treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>18 years of age.
Exclusion Criteria
* other associated visceral resections
18 Years
ALL
No
Sponsors
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University of Milan
OTHER
Responsible Party
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Prof. Guido Torzilli
Director of the Department of Surgery Head of the General and Hepatobiliary surgery unit, Clinical Professor and Principal investigator
Principal Investigators
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Guido Torzilli
Role: PRINCIPAL_INVESTIGATOR
Department of Biomedical Sciences Humanitas University, Milan
Locations
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Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan
Rozzano, Milan, Italy
Countries
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Other Identifiers
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HBF2018
Identifier Type: -
Identifier Source: org_study_id
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