Hemopatch for Prevention of Bile Leaks After Liver Resection

Bile Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753880
• Other study ID #: MUV 1.0
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: June 2021

Study information

• Verified date: October 2019
• Source: Medical University of Vienna
• Contact: Christoph Schwarz, MD., PhD
• Phone: 0043(0)1/40400/56210
• Email: christoph.a.schwarz[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Elective hepatic resection

Exclusion Criteria:

• Minor atypical hepatectomy without a plain cut surface

• Contraindications to the application of Hemopatch®

Related Conditions & MeSH terms

• Bile Leak

Intervention

Device:
• HEMOPATCH Sealing Hemostat
Hemopatch sealing hemostat used after LR to cover the resection surface

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bleeding	Postoperative bleeding that requires surgical intervention	30 days
Secondary	Abscess	Abscess that requires surgical intervention or percutaneous drainage	30 days
Secondary	Mortalitiy	Overall mortality within 30 days post liver resection	30 days