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Use of hemopatch like a control of bile leakage/sealant during liver resection surgery.

Application of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery.

Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement

Hemopatch

Standard of care include other sealant / hemostatic devices as patches or liquid/gels

Standard of care

Clara Rosso Fernández, PhD

Lydia Barrera, PhD

Miguel Angel Gómez Bravo, PhD

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.

Prospective, randomized (1:1) study of 2 treatment groups (hemopatch versus standard of care) in liver resection surgery. Non-inferiority study

Standard of Care Versus Hemopatch® During Liver Resection

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)

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

Classification A,B,C. According to International Study Group of Liver Surgery (ISGLS)

* 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.)

Death: number of patients dying during study

analysis of bilirubin (mg/dL),in the drain fluid

Total volume of blood, quantified though aspiration and drainage (Quantification of total number of deciliters (dL) of blood gathered)

Quantification of hemoglobin (mg/dL), in the drain fluid

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)

Quantification of number of packed red blood cells

Spots Global Cancer Trial Database for hemorrhage liver