Liver Neoplasms Clinical Trial
Official title:
The Influence of Two Different Hepatectomy Methods on Transection Speed and Chemokine Release From the Liver
Verified date | April 2015 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Agency for Health and Food Safety |
Study type | Interventional |
The CUSA (cavitron ultrasound surgical aspirator) is the method of choice for hepatic resection in our center. Recently a stapler-hepatectomy methods has been developed and approved for liver surgery using Covidien Endo-Gia stapler. The potential benefit of this method is a potential shorter transection time compared to the CUSA technique. Thus the investigators will perform a randomized controlled trial including 20 patients in the stapler-group and 20 patients in the CUSA control group. Primary endpoint will be transection speed. Secondary endpoints will be peri-operative (d-1, d0, d1, d3) cytokines concentration, T cell subsets, blood loss, morbidity, and a cost analysis.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients scheduled for elective major hepatic resection at the Department of General Surgery, Medical University of Vienna - Stapler hepatectomy and CUSA resection feasible based on preoperative imaging - Age equal or greater than 18 years - Informed consent Exclusion Criteria: - Minor hepatectomy - Hepatitis B, Hepatitis C, HIV infection, autoimmune disease - Inflammatory conditions of the bowel such as Crohn's Disease - Pregnancy |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Dept. of Surgery/Div. of General Surgery Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Costs and health economics | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No | |
Primary | transection speed | The transection time will be recorded by the anesthesiological team during surgery. The transection phase starts with opening the liver parenchyma after the transection line has been marked by electrocautery. It ends after complete division of the liver parenchyma. The cut surface of the resected liver will be photographed together with a 4 cm² reference scale in an exact 90° angle. The area of the liver transection surface will be calculated in cm² by setting the measured pixels of the cut surface in relation to the reference scale using Adobe Photoshop. The transection speed will expressed in cm²/min | during surgery | No |
Secondary | Perioperative cytokine concentrations | day -1, d0, d1, d3 | No | |
Secondary | Intraoperative blood loss in ml | during surgery | No | |
Secondary | Postoperative laboratory markers of liver damage | Postoperative routine laboratory markers of liver damage (aspartate aminotransferase (AST), alanine aminotransferase (ALT)), and markers of liver function (bilirubin, prothrombin time) measured on first and third postoperative day | first week after surgery | No |
Secondary | Morbidity and Mortality | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No | |
Secondary | Perioperative T-cell subsets | Day -1, 0, 1, 3 | No |
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