Ischemic Preconditioning. Prospective Comparison

NCT ID: NCT01432548

Last Updated: 2011-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-10-31

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.

Conditions

Ischemic Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

ischemic preconditioning

Surgery with ischemic preconditioning in liver resection

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General de Agudos "Dr. Cosme Argerich"

OTHER

Sponsor Role: lead

Responsible Party

Juan Marcelo Rivaldi

Ischemic preconditioning vs intermittent portal triad clamping in liver resection. Prospective Randomized Comparison

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Dr Cosme Argerich

Buenos Aires, Buenos Aires, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Javier Lendoire, MD, PhD

Role: CONTACT

jlendoire@yahoo.com.ar

5491160116898

Facility Contacts

Javier Lendoire, MD, PhD

Role: primary

• jlendoire@yahoo.com.ar

011-4121-0846

Other Identifiers

JLendoire2

Identifier Type: -

Identifier Source: org_study_id