Surgery Clinical Trial
Official title:
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.
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.
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