Hepatoprotective Effect of Remote vs Local Preconditioning of Liver

Study Overview
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Brief Summary
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The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury of remote ischemic preconditioning of the liver against local ischemic preconditioning of the liver during human liver resections.

Detailed Description
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In this randomized control study, a total of 60 patients were randomized into 3 groups: remote ischemic precondition group - RIPC (3 intervals of 5 minute right upper limb ischemia with 3 intervals of 5 minute reperfusion), local ischemic precondition group - LIPC (15 minutes of inflow liver occlusion followed by 10 minutes of reperfusion before liver transection), control group - CG (group without ischemic preconditioning before liver transection). Patients were also stratified according to the extent of the hepatectomy. Hepatoprotective effect was evaluated by comparing serum transaminase levels, bilirubin levels, albumin, and protein levels, coagulograms and pathohistological exams. We also measured flow rate by Doppler ultrasound of hepatic artery and portal vein before and after preconditioning.

Official Title
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Comparison of Hepatoprotective Effect From Ischemia-reperfusion Injury of Remote Ischemic Preconditioning of the Liver vs. Local Ischemic Preconditioning of the Liver During Human Liver Resections

Conditions
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Liver Metastases

Intervention / Treatment
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* Procedure: Preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with colorectal cancer liver metastasis all of which signed an informed consent Exclusion Criteria: having any other underlying liver disease, or preoperative increased liver transaminase, bilirubin patients with chronic cardiac, pulmonary or renal disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Remote ischemic preconditioning<br> | Procedure: Preconditioning<br>* Local ischemic preconditioning (LIPC) is process during which a short period of ischemia is followed by a period of reperfusion prior to the prolonged ischemia which seems to render organs more tolerant to the IR(ischemic-reperfusion) injury. Remote ischemic preconditioning (RIPC) involves the protection of an organ from prolonged ischemia by brief periods of ischemia and reperfusion to a remote organ.<br>|
| Active Comparator: Local ischemic preconditioning<br> | Procedure: Preconditioning<br>* Local ischemic preconditioning (LIPC) is process during which a short period of ischemia is followed by a period of reperfusion prior to the prolonged ischemia which seems to render organs more tolerant to the IR(ischemic-reperfusion) injury. Remote ischemic preconditioning (RIPC) involves the protection of an organ from prolonged ischemia by brief periods of ischemia and reperfusion to a remote organ.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in synthetic liver function | We measured residual synthetic liver function and liver ischemic-reperfusion injury by value level of bilirubin, total proteins, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamic aminotransferase (ƴGT), cholinesterase, alkaline phosphatase (AP), coagulogram. | Preoperatively, first, third and seventh postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow through the hepatic artery and portal vein | During operation we preformed Doppler ultrasonography of hepatic artery and portal vein. | Before and after preconditioning | 
| Liver histology evaluation | Liver paraffin-embedded, standard haematoxylin-eosin stained sections were analysed postoperatively to evaluate the ischemic reperfusion injury . According to Rodriguez et al. four elements of the liver histology were analysed: steatosis (micro vesicular and macro vesicular) in 4 grades, degree of sinusoidal congestion and dilatation in 3 grades, leukocyte infiltration in 3 grades and necrosis (focal, confluent, or zonal) in 3 grades.26 Each biopsy was evaluated by a single pathologist blinded to the treatment allocation. | Up to 10 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preconditioning, resection