NCT03753880

Hemopatch for Prevention of Bile Leaks After Liver Resection

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bile Leak

Interventions

Type	Name	Description
DEVICE	HEMOPATCH Sealing Hemostat	Hemopatch sealing hemostat used after LR to cover the resection surface

Timeline

• Start date: 2019-10-23
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2018-11-27
• Last updated: 2019-10-25

Locations

1 site across 1 country: Austria