Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury (annie-liver)

February 4, 2020 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital

Does Vascular Occlusion in Liver Resections Predispose to Recurrence of Malignancy in the Liver Remnant Due to 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

retrospective analysis of an internal hepatectomy database

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to malignant recurrence
Time Frame: from time of operation until time of malignant recurrence, assessed up to 15 years
recurrence-free survival
from time of operation until time of malignant recurrence, assessed up to 15 years
time to death
Time Frame: from time of operation until time of death, assessed up to 20 years
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
Time Frame: second postoperative day
aspartate aminotransferase levels
second postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aretaieion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2000

Primary Completion (ACTUAL)

December 31, 2012

Study Completion (ACTUAL)

December 31, 2012

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • liver IR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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