Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury

Study Overview
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Brief Summary
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Severe ischemic changes of the liver remnant after hepatectomy could expedite tumor recurrence on the residual liver. Our study aimed at assessing the effect of warm ischemic/reperfusion (I/R) injuries on surgery-to-local recurrence interval and patient overall survival, during major hepatectomies under inflow and outflow vascular control.

Detailed Description
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One hundred and eighteen patients were subjected to liver resection under total inflow and outflow vascular clamping and were assigned as study group. These individuals were retrospectively matched to 112 counterparts, who underwent liver surgery applying inflow and outflow vascular clamping only of the segment harboring the tumor, sparing the liver remnant from any I/R injury (control group). The two cohorts were compared regarding recurrence-free survival and overall survival.

Official Title
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Does Vascular Occlusion in Liver Resections Predispose to Recurrence of Malignancy in the Liver Remnant Due to Ischemia/Reperfusion Injury?

Conditions
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Ischemic Reperfusion Injury, Liver Injury, Cancer Recurrence, Malignancy, Liver Cancer

Intervention / Treatment
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* Procedure: selective hepatic vascular exclusion
* Procedure: semielective hepatic vascular exclusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients American Society of Anesthesiologists (ASA) distribution I to III Patients scheduled for major liver resection (≥3 segments) Exclusion Criteria: patients with extrahepatic disease patients with metastatic liver tumors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>patients subjected to major hepatectomy with vascular control of blood inflow and outflow of the whole liver | Procedure: selective hepatic vascular exclusion<br>* major hepatectomy with vascular control of blood inflow and outflow of the whole liver<br>|
| control group<br>patients subjected to major hepatectomy by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor | Procedure: semielective hepatic vascular exclusion<br>* major liver resection by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to malignant recurrence | recurrence-free survival | from time of operation until time of malignant recurrence, assessed up to 15 years | 
| time to death | overall survival | from time of operation until time of death, assessed up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aspartate aminotrasferase (AST) levels | aspartate aminotransferase levels | second postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia reperfusion injury, liver surgery, cancer recurrence, malignancy, hepatectomy