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Ischemic Preconditioning. Prospective Comparison

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01432548
Acronym
IP
Enrollment
60
Registered
2011-09-13
Start date
2011-07-31
Completion date
2012-10-31
Last updated
2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Lesions

Keywords

Ischemic, preconditioning, liver, resection

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.

Interventions

PROCEDUREischemic preconditioning

Surgery with ischemic preconditioning in liver resection

Sponsors

Hospital General de Agudos Dr. Cosme Argerich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frame
Mortality Complicationswithin 30 days after surgery

Secondary

MeasureTime frameDescription
Operative variables,markers of liver function and injury, pathological parenchymal characteristicswithin 30 days after surgeyOperative 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

Countries

Argentina

Contacts

Primary ContactJavier Lendoire, MD, PhD
jlendoire@yahoo.com.ar5491160116898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026