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Trial record 3 of 4 for:    "Alveolar echinococcosis"
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The Influence of Two Different Hepatectomy Methods on Transection Speed and Chemokine Release From the Liver

This study is not yet open for participant recruitment.
Verified February 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Klaus Kaczirek, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01785212
First received: January 23, 2013
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Liver Neoplasms
Liver Metastasis
Liver Hemangioma
Echinococcosis, Hepatic
 Device: Stapler
Device: CUSA (Cavitron ultrasonic aspirator; Valleylab, Boulder, CO)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Influence of Two Different Hepatectomy Methods on Transection Speed and Chemokine Release From the Liver

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • transection speed [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Perioperative cytokine concentrations [ Time Frame: day -1, d0, d1, d3 ] [ Designated as safety issue: No ]
  • Intraoperative blood loss in ml [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • Postoperative laboratory markers of liver damage [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
    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

  • Morbidity and Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Perioperative T-cell subsets [ Time Frame: Day -1, 0, 1, 3 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Costs and health economics [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stapler-hepatectomy
The liver parenchyma is crushed with a Pean clamp and subsequently divided using Covidien Endo-Gia™ Ultra Handle Short Staplers and Endo Gia™ TRI staple 60 mm or 45 mm AVM/AMT loading units (Covidien). Hepatic veins and portal pedicles clamped and suture ligated.
 Device: Stapler
stapler hepatectomy
Other Name: Covidien Endo-Gia™ Ultra Handle Short Staplers(Covidien)
CUSA-hepatectomy
The liver parenchyma is divided along the transection line by CUSA (Cavitron ultrasonic aspirator; Valleylab, Boulder, CO) and bipolar forceps in a two surgeon technique. Vessels of less than 2 mm in diameter are coagulated with bipolar forceps. The remaining vessels are clipped or ligated. Hepatic veins and portal pedicles clamped and suture ligated.
 Device: CUSA (Cavitron ultrasonic aspirator; Valleylab, Boulder, CO)
CUSA is a well established device used for hepatic resection using ultrasound

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  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785212

Contacts
Contact: Klaus Kaczirek, M.D. 00430(1)404005621 klaus.kaczirek@meduniwien.ac.at
Contact: Christoph Schwarz, M.D. 00430(1)404005621 christoph.a.schwarz@meduniwien.ac.at

Locations
Austria
Dept. of Surgery/Div. of General Surgery Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Klaus Kaczirek, M.D.     00430(1)404005621     klaus.kaczirek@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Klaus Kaczirek, M.D. Medical University of Vienna
  More Information

Publications:

Responsible Party: Klaus Kaczirek, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01785212     History of Changes
Other Study ID Numbers: Version 1.0
Study First Received: January 23, 2013
Last Updated: February 4, 2013
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Echinococcosis
Echinococcosis, Hepatic
Neoplasms
Hemangioma
Liver Neoplasms
Neoplasm Metastasis
Cestode Infections
Helminthiasis
Parasitic Diseases
 Liver Diseases, Parasitic
Liver Diseases
Digestive System Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013