Surgical Outcome of HCC With Portal Vein Tumor Thrombosis on the Basis of Risk Scoring

August 16, 2023 updated by: Keimyung University Dongsan Medical Center

The Prognosis After Surgical Resection in Patients With Hepatocellular Carcinoma Combined Portal Vein Tumor Thrombosis; Multicenter Retrospective Study

The goal of this multicenter retrospective cohort study is to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.

Study Overview

Status

Completed

Conditions

Detailed Description

Hepatocellular carcinoma (HCC) frequently invades the surrounding liver vasculature, with portal vein tumor thrombosis (PVTT) being the most common form of macrovascular invasion. At the time of HCC diagnosis, PVTT is detected in approximately 10%-40% of patients and is associated with an extremely poor prognosis.

In most staging systems and guidelines, HCC with PVTT, regardless of the extent of the tumor, is classified as an advanced stage, and surgical resection is not recommended as the first-line treatment. Instead, consensus guidelines such as those from the American Association of Study of Liver Disease(AASLD), the Asian Pacific Association for the Study of Liver(APASL), and the European Association for the Study of Liver(EASL) recommend systemic and targeted therapy for these patients. Despite these recommendations, experienced liver centers in Asia have been attempting surgical resection for some patients with HCC exhibiting PVTT, and the outcomes are favorable in selected patients. However, most of the studies were conducted in only one center, had a small sample size, and obtained undesirable surgical treatment outcomes in most of the patients. Thus, surgical resection has not yet been widely accepted as an effective treatment for patients with HCC and PVTT. In addition, a prognostic index that can indicate which surgical resection is beneficial in comparison with nonsurgical treatment remains unestablished. A randomized controlled trial could be the best way to compare the outcomes of surgical resection and nonsurgical treatments, but it is difficult to conduct because of difficulties in ethical approval and allocation concealment. Therefore, adequate studies with large sample sizes are needed to clarify the benefits of surgical resection in patients with HCC and PVTT and the prognostic index, which can specify the criteria for surgical resection in these patients.

This study aimed to investigate the clinical outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be helpful in determining the treatment strategy.

Study Type

Observational

Enrollment (Actual)

332

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

  • Korea, Republic of
    • DalSeo-gu
      • Daegu, DalSeo-gu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective multicenter study enrolled patients who underwent surgical resection of HCC with PVTT at 10 university-affiliated hospitals in Korea between January 2005 and December 2019. The institutional review board of each study center approved the study protocol (IRB No.:2022-03-065-003). The inclusion criteria were as follows: a) HCC with PVTT found on preoperative imaging and proven by postoperative histology whether it is viable; b) Child-Pugh class A liver function; c) no extrahepatic metastasis and concomitant malignant tumors other than HCC; d) no previous hepatic resection for HCC; and e) available medical records and/or imaging studies.

Description

Inclusion Criteria:

The patients underwent liver resection for HCC with portal vein tumor thrombosis between Jan 2005 and Dec 2019 at 10 university-affiliated hospitals in South Korea.

Exclusion Criteria:

  • Metastatic cancer & extrahepatic metastasis
  • Intrahepatic cholangiocarcinoma
  • Mixed type hepatocellular-cholangiocarcinoma
  • Recurred hepatocellular carcinoma
  • not available medical records.
  • Child-Pugh classification B or C

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: From the date of surgery until the date of patient's death from any cause, whichever came first, assessed up to November 2021.
Patient's death after surgical resection in HCC patients with portal vein tumor thrombosis
From the date of surgery until the date of patient's death from any cause, whichever came first, assessed up to November 2021.
Recurrence of tumor
Time Frame: From the date of surgery until the date of HCC recurrence, whichever came first, assessed up to November 2021.
HCC recurrence after surgical resection in HCC patients with portal vein tumor thrombosis
From the date of surgery until the date of HCC recurrence, whichever came first, assessed up to November 2021.

Collaborators and Investigators

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

Sponsor

Keimyung University Dongsan Medical Center

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 10, 2021

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

April 10, 2022

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-03-065-003

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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