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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06005883
• Other study ID #: 2022-03-065-003
• Status: Completed
• Start date: April 10, 2021
• Est. completion date: April 10, 2022

Study information

• Verified date: August 2023
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: April 10, 2022
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Portal Vein Thrombosis
• Prognosis
• Thrombosis

Locations

Country	Name	City	State
Korea, Republic of	Keimyung university Dongsan Medical Center	Daegu	DalSeo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	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.
Primary	Recurrence of tumor	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.