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

NCT06628661 | Recruiting DMC

• 2 other identifiers: PMRPG3N0051MOHW112-CMAP-M-113-000006-D
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC); Solitary Mass

Keywords

Hepatocellular carcinoma; Solitary tumor; Operable; Survival analysis; Tumor size; Microvacular invasion

Outcome Measures

Primary Outcomes (1)

• 10-year overall survival

  10-year overall survival of different cohorts

  From enrollment to the end date of 10 years or the mortality occurs.

Secondary Outcomes (2)

• 10-year disease-free survival

  From enrollment to the end date of 10 years or the mortality or recurrence occur.

• 10-year liver-specific survival

  From enrollment to the end date of 10 years or the mortality due to liver condiiton occurs.

Study Arms (2)

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

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

Interventions

Surgery for HCC larger than 6.5 cm PROCEDURE

Surgery for HCC larger than 6.5 cm without mVI

Solitary HCC larger than 6.5 cm without mVI

Surgery for HCC larger than 2 cm PROCEDURE

Surgery for HCC larger than 2 cm with mVI

Solitary HCC larger than 2 cm with mVI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Operable solitary hepatocellular carcinoma

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Medical Foundation

Taoyuan District, 330, Taiwan

RECRUITING

Related Publications (2)

• Lee CW, Yu MC, Wang CC, Lee WC, Tsai HI, Kuan FC, Chen CW, Hsieh YC, Chen HY. Liver resection for hepatocellular carcinoma larger than 10 cm: A multi-institution long-term observational study. World J Gastrointest Surg. 2021 May 27;13(5):476-492. doi: 10.4240/wjgs.v13.i5.476.

  PMID: 34122737 BACKGROUND

• Lee CW, Tsai HI, Yu MC, Wang CC, Lee WC, Yeh TS, Yeh CN, Lin CY, Kuo T, Chen HY. A proposal for T1 subclassification in hepatocellular carcinoma: reappraisal of the AJCC 8th edition. Hepatol Int. 2022 Dec;16(6):1353-1367. doi: 10.1007/s12072-022-10422-8. Epub 2022 Sep 28.

  PMID: 36169915 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: September 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)