Status:
UNKNOWN
Efficacy and Tolerability of Hemopatch After Hepatic Resection
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Hepatectomy
Cancer, Metastatic
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
* 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. * Init...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2019
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03323359
Start Date
March 17 2017
End Date
March 17 2019
Last Update
November 8 2017
Active Locations (1)
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1
Policlinico Universitario Agostino Gemelli
Rome, Italy, 00168