Efficacy and Tolerability of Hemopatch After Hepatic Resection

Study Overview
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Brief Summary
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Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen. Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost any bleeding surface encountered during a range of procedures. The Authors shown that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. They support the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries. In a recent published case report the authors reported the feasibility in using Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the procedure on cardiopulmonary bypass, which meant the patient had to be heparinized. Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to contain bleeding and seal the wound without needing any suture. These initial results lead up to future randomized clinical trials with more extensive follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient.

Detailed Description
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Advances in surgical techniques have reduced the occurrence of postoperative complications following liver resection and resulted in low surgical mortality and morbidity rates in high-volume centers. Although partial liver resections for primary or secondary hepatic malignancies are considered standard interventions, intraoperative blood loss remains a risk factor associated with major complications in liver surgery [1-3]. There are several methods for reduction of blood loss, including meticulous resection technique along anatomical planes, reduction of central venous pressure during transection of the liver parenchyma [4], and vascular occlusion techniques (i.e., inflow occlusion and total vascular occlusion) [5-7]. In addition, specific instruments were devised for liver transection, such as the ultrasonic dissector, water jet, and other, more recent developments (e.g., focal radiofrequency ablation) that allow sealing of small vessels during transection [8, 9]. In order to control diffuse bleeding and to prevent intraperitoneal complications attributed to bleeding, various topical products are used when the conventional methods, such as suture, ligation, or argon beam coagulation, fail. Currently, there are numerous products on the market which are promising a successful outcome for hemostasis. These products include gelatin, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues.

Official Title
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Exploratory Phase IV Randomized Single Blind Study Evaluating the Efficacy and Tolerability of Hemopatch in Improving Time of Hemostasis and Preventing Post-operative Complications After Hepatic Resection

Conditions
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Hepatectomy, Cancer, Metastatic, Hemostasis

Intervention / Treatment
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* Device: Hemopatch
* Procedure: Common Surgical Techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocellular carcinoma Hilar cholangiocarcinoma Adrenal cancer metastasis Breast cancer metastasis Colorectal cancer metastasis Ovarian cancer metastasis Biliary carcinoma Hemangioma Hepatic adenoma Focal nodular hyperplasia Unilocular hydatid cyst Multilocular hydatid cyst Exclusion Criteria: Trauma surgery Active sepsis around the liver Documented history of cirrhosis Pregnant or nursing women Severe coagulopathy (defined as an International normalized ratio >2.0) Severe Liver disfunction, as per clinical assessment Previous liver transplantation Laparoscopic procedure Any other intraoperative finding, which defines the no eligibility of the patient for liver resection Known hypersensitivity to bovine proteins or brilliant blue Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemopatch 45x90 mm - CE 0297 Class III<br>Hemopatch + Common surgical techniques | Device: Hemopatch<br>* Hemopatch is applied upon the verification made by the surgeon of the presence of an appropriate target bleeding site in the hepatic parenchyma. At the time point of application a stopwatch starts simultaneously. Time to hemostasis is defined as the time required to obtain successful haemostasis in a single bleeding site. At 3 minutes the inspection will be made and, if haemostasis is not achieved, the treatment is considered failed and the Principal Investigator and/or his delegates is allowed to use additional haemostatic measures.The time to haemostasis will be recorded in the patient's medical record and in the electronic Case Report Form. The bleeding site will be observed for 1 additional minute at the end of the haemostatic procedure and, of the surgery to confirm the haemostasis.<br>* Other names: BAXTER;|
| Other: Standard Surgery Technique<br>Common surgical techniques | Procedure: Common Surgical Techniques<br>* Patients undergoing liver resection for any underlying disease and with resectable mass. The list of the underlying diseases is the following (but might not be limited to): Hepatocellular carcinoma, Hilar cholangiocarcinoma, Adrenal cancer metastasis, Breast cancer metastasis, Colorectal cancer metastasis, Ovarian cancer metastasis, Biliary carcinoma, Hemangioma, Hepatic adenoma, Focal nodular hyperplasia, Unilocular hydatid cyst, Multilocular, hydatid cyst.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluated comparing the achievement of hemostasis within 3 minutes from the application of the patch | Evaluation of the improvement of the time of hemostasis | Day 0 - T3 (Surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of the post-operative complications | measurement of glucose, urea nitrogen, creatinine, sodium, potassium, calcium, total cholesterol, High Density Lipid and Low Density Lipid, triglyceride, alkaline phosphatase, Lactate Dehydrogenase, complete blood cell counts with differential and platelet counts, activated partial thromboplastin time, Prothrombin, international normalized ratio, fibrinogen, erythrocyte sedimentation rate, C-reactive Protein and Liver function tests, such as Alanine Transferase, Aspartate Transferase, Alkaline Phosphatase, bilirubin and total protein, gamma-glutamyl transferase | T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study) | 
| shorten the use of drainage tube after hepatic resection and the volume of the drainage | measurement of drain pigmentation, i.e.biliary bloody clear | T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study) | 
| the bile leaks | Abdominal ultrasound | T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study) | 
| any adverse event including, but not limited to, the length of hospital stay, rate of post-operative mortality | Incidence of Adverse Events | T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study) | 
| Intraoperative details | Evaluation of the hepatic parenchyma characteristics, intraoperative measurement of total volume of transfused blood products, type of the hepatic resection, the estimated intraoperative blood loss, the use of Pringle's maneuver | Day 0 - T3 (Surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Hemopatch, Hepatic resection, Hemostasis