Ischemic Preconditioning. Prospective Comparison (IP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hospital General de Agudos “Dr. Cosme Argerich”.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Juan Marcelo Rivaldi, Hospital General de Agudos "Dr. Cosme Argerich" Identifier:
First received: August 29, 2011
Last updated: September 12, 2011
Last verified: September 2011

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.

Condition Intervention
Ischemic Lesions
Procedure: ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ischemic Preconditioning Versus Intermittent Portal Triad Clamping in Liver Resection. Prospective Randomized Comparison

Further study details as provided by Hospital General de Agudos “Dr. Cosme Argerich”:

Primary Outcome Measures:
  • Mortality Complications [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Operative variables,markers of liver function and injury, pathological parenchymal characteristics [ Time Frame: within 30 days after surgey ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: ischemic preconditioning
    Surgery with ischemic preconditioning in liver resection
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.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01432548

Contact: Javier Lendoire, MD, PhD 5491160116898

Hospital Dr Cosme Argerich Recruiting
Buenos Aires, Argentina
Contact: Javier Lendoire, MD, PhD    011-4121-0846    •   
Sponsors and Collaborators
Hospital General de Agudos “Dr. Cosme Argerich”
  More Information

No publications provided

Responsible Party: Juan Marcelo Rivaldi, Ischemic preconditioning vs intermittent portal triad clamping in liver resection. Prospective Randomized Comparison, Hospital General de Agudos "Dr. Cosme Argerich" Identifier: NCT01432548     History of Changes
Other Study ID Numbers: JLendoire2
Study First Received: August 29, 2011
Last Updated: September 12, 2011
Health Authority: Argentina: Ministry of Health

Keywords provided by Hospital General de Agudos “Dr. Cosme Argerich”:

Additional relevant MeSH terms:
Pathologic Processes processed this record on October 06, 2015