NCT03753880

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

November 19, 2018

Last Update Submit

October 23, 2019

Conditions

Bile Leak

Keywords

Liver resectionBile leaksOutcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bleeding

    30 days

  • Abscess

    30 days

  • Mortalitiy

    30 days

Study Arms (1)

Hemopatch

EXPERIMENTAL

Hemopatch used to cover the resection surface after LR

Device: HEMOPATCH Sealing Hemostat

Interventions

HEMOPATCH Sealing HemostatDEVICE

Hemopatch sealing hemostat used after LR to cover the resection surface

Hemopatch

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective hepatic resection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Christoph Schwarz, MD., PhD

CONTACT

0043(0)1/40400/56210christoph.a.schwarz@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 27, 2018

Study Start

October 23, 2019

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

AU(1)