Hemopatch for Prevention of Bile Leaks After Liver Resection

Medical University of Vienna

Status: Unknown

Conditions: Bile Leak

Treatments: Device: HEMOPATCH Sealing Hemostat

Study type: Interventional

Funder types: Other

Identifiers

NCT03753880

MUV 1.0

Details and patient eligibility

About

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.

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective hepatic resection

Exclusion criteria

• Minor atypical hepatectomy without a plain cut surface
• Contraindications to the application of Hemopatch®

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Hemopatch

Experimental group

Description:

Hemopatch used to cover the resection surface after LR

Treatment:

Device: HEMOPATCH Sealing Hemostat