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

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT06005883

Collaborator

(none)

332

Enrollment

Location

Actual Duration (Months)

27.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Portal Vein Thrombosis Prognosis

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 Design

Study Type:

Observational

Actual Enrollment :

332 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 10, 2021

Actual Primary Completion Date :

Aug 10, 2021

Actual Study Completion Date :

Apr 10, 2022

Outcome Measures

Primary Outcome Measures

Death [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
Recurrence of tumor [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.