Spots Global Cancer Trial Database for Standard of Care Versus Hemopatch® During Liver Resection

Study Description

Brief Summary: 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: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial