Standard of Care Versus Hemopatch® During Liver Resection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Liver Cancer, Hemorrhage Liver, Bile Leak, Surgery, Tumor Liver

Intervention / Treatment
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* Other: Hemopatch
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized (1:1) study of 2 treatment groups (hemopatch versus standard of care) in liver resection surgery. Non-inferiority study
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of bile leakage | 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 | 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 | Quantification of hemoglobin (mg/dL), in the drain fluid | From the surgery day until day 30 | 
| Bleeding complications | 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 | Quantification of number of packed red blood cells | From the surgery day until day 30 |