Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery

Hepatocellular Carcinoma Clinical Trial

— HSL2012-06  

Official title:

Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01690715
• Other study ID #: HSL 2012/06
• Status: Terminated
• Start date: July 2012
• Est. completion date: August 30, 2012

Study information

• Verified date: November 2023
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. The study aims to determine the prognostic value of vascular complications related to cancer and to evaluate the survival rate of these patients, comparing the data with those reported in the literature.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: August 30, 2012
• Est. primary completion date: August 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection, with or without hepatic cirrhosis association;

• presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels;

Exclusion Criteria:

• Patients undergoing prior systemic treatment;

• Patients presenting incomplete data that do not allow their classification according to the stratification models;

• Patients whose information of progression or death can not be recovered;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatic Portal Vein Tumor Invasion
• Hepatocellular Carcinoma
• Portal Vein Thrombosis
• Thrombosis

Locations

Country	Name	City	State
Brazil	Hospital Sírio-Libanês	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis (disease graduation)	The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis.	1 to 3 years
Secondary	Survival rate in years	Determination of the survival rate within 1 to 3 years for those submitted to curative hepatectomy.	1 to 3 years
Secondary	Relation established between survival and degree of underlying liver dysfunction	Investigate a possible relationship between survival and degree of underlying liver dysfunction in patients with thrombosis or portal vein invasion in patients undergoing curative hepatectomy.	1 to 3 years