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Completed

NCT Number: NCT04257240

Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury

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.

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Key information

Conditions

Ischemic Reperfusion Injury Cancer Recurrence Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Liver Cancer Liver Diseases Liver Injury Liver Neoplasms Malignancy Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selective hepatic vascular exclusion

Procedure

major hepatectomy with vascular control of blood inflow and outflow of the whole liver

semielective hepatic vascular exclusion

Procedure

major liver resection by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor

Primary outcomes

  1. time to malignant recurrence

    Time frame: from time of operation until time of malignant recurrence, assessed up to 15 years

    recurrence-free survival

  2. time to death

    Time frame: from time of operation until time of death, assessed up to 20 years

    overall survival

Secondary outcomes

  1. aspartate aminotrasferase (AST) levels

    Time frame: second postoperative day

    aspartate aminotransferase levels

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

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

Acronym: annie-liver

Important dates

Study start
2000
Primary completion
2012
Study completion
2012
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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