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

NCT ID: NCT06005883

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 332 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-10
• Study Completion Date: 2022-04-10

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.

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.

Conditions

Hepatocellular Carcinoma; Portal Vein Thrombosis; Prognosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Keimyung university Dongsan Medical Center

Daegu, DalSeo-gu, South Korea

Countries

South Korea

Other Identifiers

2022-03-065-003

Identifier Type: -

Identifier Source: org_study_id