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Hemopatch for Prevention of Bile Leaks After Liver Resection

NCT ID: NCT03753880

Last Updated: 2019-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-23

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bile Leak

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hemopatch

Hemopatch used to cover the resection surface after LR

Group Type EXPERIMENTAL

HEMOPATCH Sealing Hemostat

Intervention Type DEVICE

Hemopatch sealing hemostat used after LR to cover the resection surface

Interventions

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HEMOPATCH Sealing Hemostat

Hemopatch sealing hemostat used after LR to cover the resection surface

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elective hepatic resection

Exclusion Criteria

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

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Christoph Schwarz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Christoph Schwarz, MD., PhD

Role: CONTACT

[email protected]
0043(0)1/40400/56210

Facility Contacts

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Christoph Schwarz, MD., PhD

Role: primary

[email protected]
0043(0)40400/56210

Klaus Kaczirek, MD.

Role: backup

[email protected]
0043(0)1/40400/56210

Other Identifiers

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MUV 1.0

Identifier Type: -

Identifier Source: org_study_id

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