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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03753880

Enrollment

Registered

2018-11-27

Start date

2019-10-23

Completion date

2021-06-30

Last updated

2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Leak

Keywords

Liver resection, Bile leaks, Outcome

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.

Interventions

DEVICEHEMOPATCH Sealing Hemostat

Hemopatch sealing hemostat used after LR to cover the resection surface

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Elective hepatic resection

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Austria

Contacts

Primary ContactChristoph Schwarz, MD., PhD

christoph.a.schwarz@meduniwien.ac.at0043(0)1/40400/56210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026