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Ischemic Preconditioning. Prospective Comparison (IP)

This study is currently recruiting participants.
Verified September 2011 by Hospital General de Agudos “Dr. Cosme Argerich”
Sponsor:
Information provided by (Responsible Party):
Juan Marcelo Rivaldi, Hospital General de Agudos "Dr. Cosme Argerich"
ClinicalTrials.gov Identifier:
NCT01432548
First received: August 29, 2011
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432548

Contacts
Contact: Javier Lendoire, MD, PhD 5491160116898 jlendoire@yahoo.com.ar

Locations
Argentina
Hospital Dr Cosme Argerich Recruiting
Buenos Aires, Argentina
Contact: Javier Lendoire, MD, PhD     011-4121-0846     • jlendoire@yahoo.com.ar    
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"
ClinicalTrials.gov 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”:
Ischemic
preconditioning
liver
resection

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013