Ischemic Preconditioning. Prospective Comparison

Ischemic Lesions Clinical Trial

— IP  

Official title:

Ischemic Preconditioning Versus Intermittent Portal Triad Clamping in Liver Resection. Prospective Randomized Comparison

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01432548
• Other study ID #: JLendoire2
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2011
• Last updated: September 12, 2011
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2011
• Source: Hospital General de Agudos “Dr. Cosme Argerich”
• Contact: Javier Lendoire, MD, PhD
• Phone: 5491160116898
• Email: jlendoire[@]yahoo.com.ar
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Lesions

Intervention

Procedure:
• ischemic preconditioning
Surgery with ischemic preconditioning in liver resection

Locations

Country	Name	City	State
Argentina	Hospital Dr Cosme Argerich	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Agudos “Dr. Cosme Argerich”

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Complications		within 30 days after surgery	Yes
Secondary	Operative variables,markers of liver function and injury, pathological parenchymal characteristics	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	within 30 days after surgey	No