Standard of Care Versus Hemopatch® During Liver Resection (IBERLIVER)

November 8, 2017 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Standard of Care Versus a New Collagen and Polyethylene Glycol Haemostatic/Sealant Patch (Hemopatch) During Liver Resection. A Multicentre, Non-inferiority Prospective Randomized Study (IBERLIVER-study)

This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Liver resection is the only potentially curative treatment in malignant or benign hepatobiliary lesions. Biliary leakage is a postoperative complication (5-10%) which may have considerable consequences. Surgical techniques and devices to facilitate the control of bile leakage have been developed in the last decades and have minimized operative risks of liver resection. Nevertheless, hepatic parenchymal transection can be associated with bile leakage due to the division of small ducts. In order to achieve control over parenchyma from the section surface and to prevent intraperitoneal complications attributed to bile leakage/bleeding various locally applicable agents are in use. This control of bile leakage include fibrin sealant and synthetic glues. Evidence from randomized controlled trials regarding the use of fibrin sealants on their own or combined with a collagenfleece has shown Little efficacy.

A new collagen and polyethylene glycol hemostatic/sealant patch (Hemopatch) [Baxter, Vienna, Austria] is indicated for local hemostasis of capillary bleeding and bleeding of parenchymal organs. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus providing an additional impetus as a sealant agent.

The investigators aim to demonstrate the sealing capability of hemopatch and to prove its non-inferiority to the standard of care (may include other sealant / hemostatic devices as patches or liquid/gels). There will be 2 groups to compare. The study group where Hemopatch is applied at the end of surgery. And the control group, where standard of care measures will be applied at the end of surgery. The end-point is the assessment of control of bile leakage at 1, 2, 3, and 4 day, during the hospital stay and or at 30 days for both treatment group. The secondary end-points are bleeding complications (re-bleeding, hematoma formation), volume of fluid drained on day 1 to day 4 after surgery, hemoglobin variation from pre-operative until discharge and post-operatory complications until 30th day pos-op.

Study Type

Interventional

Enrollment (Anticipated)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: ≥18 years.
  • Patients with an indication for open liver resection (segmental or non-segmental).
  • Target bleeding site of generalized bleeding that persists on the cut surface of the liver in which hemostasis cannot be achieved by conventional methods.
  • Willing and able to complete the clinical trial procedures, as described in the protocol.
  • Signed written informed consent to participate in this clinical trial.

Exclusion Criteria:

  • Presence of coagulation disorder, Klatskin tumour. Cirrhosis, re-hepatectomies and biliary resections
  • Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints.
  • Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamic acid, activated factor VII, fibrinogen and aprotinin.
  • Known allergy or hypersensitivity to a component of the investigational treatments Hemopatch® ,to riboflavin or to proteins of bovine origin.
  • Pregnancy or breast-feeding.
  • Inability to understand the nature and the extent of the trial and the procedures required.

Criteria to be checked during surgery (intraoperative exclusion criteria):

  • Infected wound area.
  • Persistent major bleeding after primary hemostasis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hemopatch
Use of hemopatch like a control of bile leakage/sealant during liver resection surgery.
Other: Hemopatch
Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement
ACTIVE_COMPARATOR: Standard of care
Application of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery.
Other: Standard of care
Standard of care include other sealant / hemostatic devices as patches or liquid/gels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of bile leakage
Time Frame: From day 1 to day 4
analysis of bilirubin (mg/dL),in the drain fluid
From day 1 to day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: From the surgery day until day 30
Total volume of blood, quantified though aspiration and drainage (Quantification of total number of deciliters (dL) of blood gathered)
From the surgery day until day 30
Analysis of hemoglobin
Time Frame: From the surgery day until day 30
Quantification of hemoglobin (mg/dL), in the drain fluid
From the surgery day until day 30
Bleeding complications
Time Frame: From the surgery day until day 30
Presence (YES or NO compatible imagen of hemorrhage )of post-hepatectomy hemorrhage or Hematoma formation (Valid imaging tests of presence or absence can be checked by : abdomen ecography, TAC or RNM)
From the surgery day until day 30
Transfusion requirements
Time Frame: From the surgery day until day 30
Quantification of number of packed red blood cells
From the surgery day until day 30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bile leakage severity
Time Frame: From the surgery day until day 30
Classification A,B,C. According to International Study Group of Liver Surgery (ISGLS)
From the surgery day until day 30
Morbidity
Time Frame: From the surgery day until day 30
  • Postoperative Ileus (refers to obstipation and intolerance of oral intake due to non mechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal or non abdominal surgery)
  • Allergic reaction (Signs and symptoms are urticarial rash; pruritus; flushing; angioedema of the face, extremities, or laryngeal tissues (leading to throat tightness with stridor, or rarely asphyxiation); wheezing; gastrointestinal symptoms; and/or hypotension after use Hemopatch)
  • Intrabdominal Infection (It describes a diverse set of diseases. It is broadly defined as peritoneal inflammation in response to microorganisms, resulting in purulence in the peritoneal cavity.)
From the surgery day until day 30
Mortality
Time Frame: From the surgery day until day 30
Death: number of patients dying during study
From the surgery day until day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: Miguel Angel Gómez Bravo, PhD, Hospitales Universitarios Virgen del Rocío

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (ACTUAL)

May 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBERLIVER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data for IPD is planned to be shared with all participants within 6 months of data completion

IPD Sharing Time Frame

12 MONTHS

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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