Hemopatch for Prevention of Bile Leaks After Liver Resection | NCT03753880

Studies
Hemopatch for Prevention of Bile Leaks After Liver Resection

NCT03753880

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Oct 25, 2019Actual

Enrollment

71Estimated

Phase

Not Applicable

Conditions

Bile Leak

Interventions

HEMOPATCH Sealing Hemostat

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2019Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Nov 19, 2018

First Submission Date that Met QC Criteria

Nov 23, 2018

First Posted Date

Nov 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2019

Last Update Posted Date

Oct 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christoph Schwarz, Principal Investigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemopatch	Experimental	Hemopatch used to cover the resection surface after LR	Device: HEMOPATCH Sealing Hemostat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HEMOPATCH Sealing Hemostat	Device	Hemopatch sealing hemostat used after LR to cover the resection surface	Hemopatch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Bleeding	Postoperative bleeding that requires surgical intervention	30 days
Abscess	Abscess that requires surgical intervention or percutaneous drainage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective hepatic resection

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Schwarz, MD., PhD	Contact	0043(0)1/40400/56210		christoph.a.schwarz@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Vienna	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided