Ischemic Lesions Clinical Trial
Official title:
Ischemic Preconditioning Versus Intermittent Portal Triad Clamping in Liver Resection. Prospective Randomized Comparison
Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion) causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can lead to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to protect the liver parenchyma during liver resection consists of an initial flow clamping for 10 minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad clamping during transection.
Detailed Description:
This is a prospective controlled trial, conducted between July 2011 and July 2012. This
study has been initiated by Liver & Transplant Division, Hospital Dr Cosme Argerich, Buenos
Aires Argentina. The protocol was approved by ethics committees and an informed consent was
obtained from each patient before they were enrolled. Sixty patients were randomized to
either receive ischemic preconditioning prior to liver resection under intermittent pedicle
clamping or Intermittent Pringle ischemia. Ischemic preconditioning was performed through a
sequence of 10 minutes vascular inflow occlusion and 10 minutes of reperfusion prior to
continuous pedicle clamping during resection. Intermittent pedicle clamping was conducted
through a sequence of 15 minutes of vascular inflow occlusion and 5 minutes of reperfusion.
The randomization process which was centralized was held in the operating room after
inclusion criteria had been check and exclusion criteria ruled out.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment