Clinical Trial: The Influence of Two Different Hepatectomy Methods on Transection Speed and Chemokine Release From the Liver

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Influence of Two Different Hepatectomy Methods on Transection Speed and Chemokine Release From the Liver

Brief Summary: 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.

Detailed Summary:

Many different techniques of parenchymal transection are used in hepatic surgery. In a systematic review, there were no significant differences in morbidity (including bile leak), mortality, routine markers of liver parenchymal injury or dysfunction and length of hospital stay irrespective of the method used for parenchymal transection. This Cochrane review analyzed studies comparing the following transection devices: CUSA (cavitron ultrasound surgical aspirator) versus clamp-crush (two trials); radiofrequency dissecting sealer versus clamp-crush (two trials); sharp dissection versus clamp-crush technique (one trial); and hydrojet versus CUSA (one trial). The clamp-crush technique appeared to have the lowest blood loss and lowest transfusion requirements compared to the other techniques.

However, even in specialized centers morbidity and mortality rates of hepatic resections are still in the range of 45% and 3% respectively and uncertainty persists regarding the optimal technique of transection. Local experience seems to be the most important factor for the choice of the transection method. An innovative technique is stapler hepatectomy using Covidien Endo-Gia™ Ultra Handle Short Staplers and Endo Gia™ TRI staple 60mm or 45 mm AVM/AMT loading units (Covidien). A randomized controlled trial (CRUNSH trial) to evaluate the intraoperative blood loss of stapler hepatectomy compared to the clamp-crushing technique is currently under way.

The CUSA technique is well established in many centers including ours with excellent morbidity and mortality rates. However, it has been shown that CUSA has a longer transection speed than the clamp-crush technique (with vascular occlusion). The investigators of the CRUNSH trial hypothesize that stapler hepatectomy technique might also be comparable or more favorable to clamp-crushin
Sponsor: Medical University of Vienna

Current Primary Outcome: transection speed [ Time Frame: during surgery ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Perioperative cytokine concentrations [ Time Frame: day -1, d0, d1, d3 ]
  • Intraoperative blood loss in ml [ Time Frame: during surgery ]
  • Postoperative laboratory markers of liver damage [ Time Frame: first week after surgery ]
    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 ]
  • Perioperative T-cell subsets [ Time Frame: Day -1, 0, 1, 3 ]


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: January 23, 2013
Date Started: March 2013
Date Completion:
Last Updated: April 6, 2015
Last Verified: April 2015