Ten-Year Outcomes of Operable Solitary Hepatocellular Carcinoma Patients: Impact of Tumor Size Over 6.5 Cm and Microvascular Invasion

November 18, 2024 updated by: Chang Gung Memorial Hospital

The goal of this study is to evaualte the impact of tumor size and microvascular invasion among patients with solitary hepatocellualr carcinoma and post operation. The main questions it aims to answer are:

Does the tumor size have more impact on the survival and recurrence than microvascular invasion among solitary operable hepatocellular carcinoma patients?

Researchers will retrospectively analyze the prospectively collected clinical database during January 2022 and December 2019 to see whether tumor size more than 6.5 cm or microvascular invasion.

The solitary operable hepatocellular carcinoma patients would be classified based on the status of microvascular invasion and tumor size, and the outcome would be evaluated among different sub-populations of the feasible subjects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Data source The study utilized the Chang Gung Research Database (CGRD), an extensive repository of electronic medical records maintained by Chang Gung Memorial Hospital (CGMH) across multiple medical centers and hospitals in Taiwan. Established for administrative and insurance purposes, the CGRD includes comprehensive data on patient demographics, diagnoses, treatments, and outcomes. It covers a significant portion of Taiwan's medical services, with detailed records on outpatient, emergency, and inpatient visits. Notably, the CGRD also includes a cancer registry with thorough documentation of diagnoses, staging, treatment modalities, recurrence, and mortality data. All data in cancer registry database were curated manually and make this information highly reliable1. Diagnoses are coded using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) before 2016 and International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) thereafter, with all cancer registry entries manually verified for accuracy. This makes the CGRD an invaluable resource for clinical research. The CGRD's extensive coverage of Taiwan's medical landscape, including a significant proportion of both inpatient and outpatient services (20% of all cancer patients' data and about 34% outpatient information in Taiwan), underscores its utility as an excellent data source for robust clinical research. Previous studies have elaborated on the CGRD's structure and content, reinforcing its role as a key resource for healthcare studies.

Study design and population The study initially included all incident HCC patients from January 2002 to December 2018 by using ICD-9-CM codes 155 and ICD-10-CM codes C22. To ensure the population to be analyzed, several exclusion criteria were applied. Patients who did not receive any treatment after diagnosis were excluded to avoid confounding survival outcomes. Age was another critical factor; patients younger than 18 or older than 80 years were excluded to eliminate potential age-related biases in survival analysis. Additionally, patients with missing tumor size were excluded, as tumor size is a crucial variable in assessing prognosis and treatment decisions. Errors in survival or recurrence status or date were also excluded to maintain data integrity. Lastly, patients deemed non-operable were excluded to focus on those who could potentially benefit from surgical intervention. Furthermore, patients who did not fall into the pT1N0M0 or pT2N0M0 staging categories were excluded to ensure only early-stage patients were enrolled. The remaining patients were then divided into two groups based on their stage, in which subjects would be separated by TNM staging pT1N0M0 (solitary HCC) and pT2N0M0 (solitary HCC with mVi or multiple HCCs with none size < 5 cm). Within the pT1N0M0 group, patients who died within 30 days post-surgery were excluded to avoid perioperative mortality bias. Additionally, patients with a tumor size of ≤ 2cm were excluded to focus on more clinically significant tumors. Two subgroups, subjects with tumor size > 2cm and ≤ 6.5cm and > 6.5cm, were further obtained according to our previous report that 6.5 cm would be the cut-off value of pT1 subjects with different prognosis. For the pT2N0M0 group, similar exclusions were made for patients who died within 30 days post-surgery and for errors in the Child score. This group was further categorized into solitary tumor with microvascular invasion (mVI) and multiple tumors with none smaller than 5cm. Also, tumor size 6.5 cm was used to classify subjects with solitary tumor with mVi. The outcomes were compared among different groups of enrolled subjects to realize the associations between operation outcomes and HCC with mVi and tumor size over or below 6.5 cm among solitary HCC patients. This study, approved by the Institutional Review Board of the Chang Gung Medical Foundation, leverages the CGRD's rich data repository to conduct a retrospective cohort analysis (IRB No.: 202300142B0).

Study Type

Observational

Enrollment (Estimated)

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

  • Taiwan
      • Taoyuan, Taiwan, 330
        • Recruiting
        • Chang Gung Medical Foundation
        • Contact:
        • Contact:
          • Hsing-Yu Chen, M.D., Ph.D.

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

No

Sampling Method

Non-Probability Sample

Study Population

The study population would include different groups of enrolled subjects to realize the associations between operation outcomes and HCC with microvascular invasions and tumor size over or below 6.5 cm among solitary HCC patients.

Description

Inclusion Criteria:

  • Operable solitary hepatocellular carcinoma

Exclusion Criteria:

  • Not pT1N0M0 or pT2N0M0
  • Missing tumor size
  • Errors in survival/recurrence dates or status

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
Solitary HCC larger than 6.5 cm without mVI
Operable solitary HCC larger than 6.5 cm without mVI
Procedure: Surgery for HCC larger than 6.5 cm
Surgery for HCC larger than 6.5 cm without mVI
Solitary HCC larger than 2 cm with mVI
Operable solitary HCC larger than 2 cm with mVI
Procedure: Surgery for HCC larger than 2 cm
Surgery for HCC larger than 2 cm with mVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-year overall survival
Time Frame: From enrollment to the end date of 10 years or the mortality occurs.
10-year overall survival of different cohorts
From enrollment to the end date of 10 years or the mortality occurs.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-year disease-free survival
Time Frame: From enrollment to the end date of 10 years or the mortality or recurrence occur.
10-year disease-free survival of different cohorts
From enrollment to the end date of 10 years or the mortality or recurrence occur.
10-year liver-specific survival
Time Frame: From enrollment to the end date of 10 years or the mortality due to liver condiiton occurs.
10-year liver-specific survival of different cohorts
From enrollment to the end date of 10 years or the mortality due to liver condiiton occurs.

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial 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)

September 30, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMRPG3N0051
  • MOHW112-CMAP-M-113-000006-D (Other Identifier: The Ministry of Health and Welfare, Taiwan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD would be available upon adequte request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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