Hemopatch for Prevention of Bile Leaks After Liver Resection

Study Overview
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Brief Summary
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In liver surgery bile leaks are still a major cause of postoperative morbidity with the need for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the fibrin-coated collagen patch in an animal model. This might be attributed to an improved tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the hepatic resection surface may also serve as a mechanical sealant of bile ducts thus preventing biliary leakage. To date, there exists no study including a sufficient number of patients to clarify whether sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks and data regarding the expected difference in the incidence of biliary complications are lacking.

Official Title
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Efficacy of NHS-PEG (Pentaerythirol Polyethylene Glycol Ether Tetra-succinimidyl Glutarate) Coated Collagen Patch (Hemopatch®) for Prevention of Bile Leaks After Liver Resection

Conditions
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Bile Leak

Intervention / Treatment
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* Device: HEMOPATCH Sealing Hemostat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective hepatic resection Exclusion Criteria: Minor atypical hepatectomy without a plain cut surface Contraindications to the application of Hemopatch®

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemopatch<br>Hemopatch used to cover the resection surface after LR | Device: HEMOPATCH Sealing Hemostat<br>* Hemopatch sealing hemostat used after LR to cover the resection surface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bile leaks | biliary leak is defined as bilirubin concentration in the abdominal drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or biliary peritonitis | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Postoperative bleeding that requires surgical intervention | 30 days | 
| Abscess | Abscess that requires surgical intervention or percutaneous drainage | 30 days | 
| Mortalitiy | Overall mortality within 30 days post liver resection | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver resection, Bile leaks, Outcome