Ischemic Preconditioning. Prospective Comparison

Not Applicable

• Conditions: Ischemic Lesions

• Registration Number: NCT01432548
• Lead Sponsor: Hospital General de Agudos "Dr. Cosme Argerich"

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-29
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-12
• Last Update Submitted: 2011-09-12
• Study First Posted: 2011-09-13
• Last Update Posted: 2011-09-13
• Primary Completion: 2012-07
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients' age ≥ 18 years old
• Portal vein embolization allowed

Exclusion Criteria

• laparoscopic liver resection
• pregnant women
• lack of patient consent
• lack of acceptance of the operating surgeon
• Hilar cholangiocarcinoma
• Simultaneous hepaticojejunostomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality Complications	within 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Operative variables,markers of liver function and injury, pathological parenchymal characteristics	within 30 days after surgey	Operative time Transection time Operative blood loss Transection area Intraoperative haemodynamic and gases parameters (CVP, MAP) Requirement of blood products. ICU and total length of hospital stay Markers of liver function (Bilirrubin, prothtrombin time) Markers of liver injury (aspartate aminotransferase (AST), alanine aminotransferase (ALT) Pathological parenchymal characteristics

Trial Locations

Locations (1)

Hospital Dr Cosme Argerich; 🇦🇷 Buenos Aires, Argentina