Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

February 11, 2023 updated by: TingBo Liang, Zhejiang University

The Guiding Value of Tumor Micronecrosis for Using Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310009
        • the First Affiliated Hospital, School of Medicine, Zhejiang University

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From June 2014 to April 2018, HCC patients who underwent liver resection in our center were retrospectively reviewed.

Description

Inclusion Criteria:

  • (1) pathologically confirmed HCC (2) achievement of R0 resection.

Exclusion Criteria:

  • (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
micronecrosis(+) group
Procedure: transcatheter arterial chemoembolization
transcatheter arterial chemoembolization after liver resection
micronecrosis(-) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: after liver resection until June 1, 2020
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
after liver resection until June 1, 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival
Time Frame: after liver resection until June 1, 2020
the number of months from the date of surgery to the date of first confirmable recurrence or death
after liver resection until June 1, 2020

Collaborators and Investigators

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

Sponsor

Zhejiang University

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)

April 30, 2020

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

April 14, 2022

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (ACTUAL)

April 28, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTHCC

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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