Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury

Completed

• Conditions: Liver Cancer; Liver Injury; Malignancy; Ischemic Reperfusion Injury; Cancer Recurrence
• Interventions: Procedure: selective hepatic vascular exclusion; Procedure: semielective hepatic vascular exclusion

• Registration Number: NCT04257240
• Lead Sponsor: Aretaieion University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2012-12-31
• Study Completion: 2012-12-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	selective hepatic vascular exclusion	patients subjected to major hepatectomy with vascular control of blood inflow and outflow of the whole liver
control group	semielective hepatic vascular exclusion	patients subjected to major hepatectomy by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor

Primary Outcome Measures

Name	Time	Method
time to malignant recurrence	from time of operation until time of malignant recurrence, assessed up to 15 years	recurrence-free survival
time to death	from time of operation until time of death, assessed up to 20 years	overall survival

Secondary Outcome Measures

Name	Time	Method
aspartate aminotrasferase (AST) levels	second postoperative day	aspartate aminotransferase levels