Hemopatch for Prevention of Bile Leaks After Liver Resection

Not Applicable

• Conditions: Bile Leak
• Interventions: Device: HEMOPATCH Sealing Hemostat

• Registration Number: NCT03753880
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-27
• Status Verified: 2019-10
• Study Start: 2019-10-23
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Elective hepatic resection

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemopatch	HEMOPATCH Sealing Hemostat	Hemopatch used to cover the resection surface after LR

Primary Outcome Measures

Name	Time	Method
Bile leaks	30 days	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

Secondary Outcome Measures

Name	Time	Method
Bleeding	30 days	Postoperative bleeding that requires surgical intervention
Mortalitiy	30 days	Overall mortality within 30 days post liver resection
Abscess	30 days	Abscess that requires surgical intervention or percutaneous drainage

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria