Hepatectomy Clinical Trial
Official title:
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
- 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.
Status | Recruiting |
Enrollment | 98 |
Est. completion date | March 17, 2019 |
Est. primary completion date | November 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Universitario Agostino Gemelli | Rome |
Lead Sponsor | Collaborator |
---|---|
Policlinico Universitario Agostino Gemelli | Baxter Healthcare Corporation |
Italy,
Alkozai EM, Lisman T, Porte RJ. Bleeding in liver surgery: prevention and treatment. Clin Liver Dis. 2009 Feb;13(1):145-54. doi: 10.1016/j.cld.2008.09.012. — View Citation
Fingerhut A, Uranues S, Ettorre GM, Felli E, Colasanti M, Scerrino G, Melfa GI, Raspanti C, Gulotta G, Meyer A, Oberhoffer M, Schmoeckel M, Weltert LP, Vignolini G, Salvi M, Masieri L, Vittori G, Siena G, Minervini A, Serni S, Carini M. European Initial H — View Citation
Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD006880. doi: 10.1002/14651858.CD006880.pub2. Review. — View Citation
Imamura H, Seyama Y, Kokudo N, Maema A, Sugawara Y, Sano K, Takayama T, Makuuchi M. One thousand fifty-six hepatectomies without mortality in 8 years. Arch Surg. 2003 Nov;138(11):1198-206; discussion 1206. — View Citation
Imkamp F, Tolkach Y, Wolters M, Jutzi S, Kramer M, Herrmann T. Initial experiences with the Hemopatch® as a hemostatic agent in zero-ischemia partial nephrectomy. World J Urol. 2015 Oct;33(10):1527-34. doi: 10.1007/s00345-014-1404-4. Epub 2014 Sep 20. — View Citation
Ishizaki Y, Yoshimoto J, Miwa K, Sugo H, Kawasaki S. Safety of prolonged intermittent pringle maneuver during hepatic resection. Arch Surg. 2006 Jul;141(7):649-53; discussion 654. — View Citation
Jainandunsing JS, Al-Ansari S, Woltersom BD, Scheeren TW, Natour E. Novel hemostatic patch achieves sutureless epicardial wound closure during complex cardiac surgery, a case report. J Cardiothorac Surg. 2015 Jan 27;10:12. doi: 10.1186/s13019-015-0215-z. — View Citation
Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; d — View Citation
Jones RM, Moulton CE, Hardy KJ. Central venous pressure and its effect on blood loss during liver resection. Br J Surg. 1998 Aug;85(8):1058-60. — View Citation
Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HP — View Citation
Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6. — View Citation
Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub — View Citation
Öllinger R, Mihaljevic AL, Schuhmacher C, Bektas H, Vondran F, Kleine M, Sainz-Barriga M, Weiss S, Knebel P, Pratschke J, Troisi RI. A multicentre, randomized clinical trial comparing the Verisetâ„¢ haemostatic patch with fibrin sealant for the management o — View Citation
Poon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective databa — View Citation
Poon RT. Current techniques of liver transection. HPB (Oxford). 2007;9(3):166-73. doi: 10.1080/13651820701216182. — View Citation
Smyrniotis V, Farantos C, Kostopanagiotou G, Arkadopoulos N. Vascular control during hepatectomy: review of methods and results. World J Surg. 2005 Nov;29(11):1384-96. Review. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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