Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension

January 30, 2024 updated by: Tang-Du Hospital

Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension: A Chinese Multicentre Retrospective Cohort Study

Clinically significant portal hypertension limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. HCC patients with CPSH are heterogeneous and treatment allocation remains controversial. The aim of this study was to compare the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in these populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3000

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
    • Shaanxi
      • Xian, Shaanxi, China, 710000
        • Tangdu Hospital
      • Xian, Shaanxi, China, 710000
        • Xijing Hospital

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

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Study data were extracted from a nationwide database of HCC patients treated at 15 Chinese centres between January 2012 and December 2022. We included patients who were diagnosed with HCC according to the American Association for the Study of the Liver Disease/European Association for the Study of the Liver Guidelines and who received conventional liver resection or transarterial chemoembolisation

Description

Inclusion Criteria:

  • HCC patients treated conventional liver resection or transarterial chemoembolisation

Exclusion Criteria:

  • (1) presence of types III/IV portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion; (2) presence of extrahepatic spread (EHS); (3) underwent previous treatments; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) >1; (5) diffuse tumor nodules; (6) combined with other tumours or severe cardiac, cerebral, and renal insufficiency; (7) non-Clinically significant portal hypertension（CSPH）, and (8) absence of baseline information

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
liver resection
transarterial chemoembolisation
Procedure: transarterial chemoembolisation
During transarterial chemoembolisation（TACE）, a vascular catheter was selectively inserted into the tumour-feeding artery with an injection containing a mixture of doxorubicin (10-50 mg) and lipiodol (2-20 mL), followed by embolisation using gelatin sponge particles. TACE was repeated when residual viable tumours were confirmed or new lesions developed in patients with adequate liver function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival rate
Time Frame: 5 year
overall survival rate
5 year

Collaborators and Investigators

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

Sponsor

Tang-Du Hospital

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, 2023

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tangdu Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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