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

NCT01690715 | Terminated DMC

• 1 other identifier: HSL 2012/06
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Portal Vein Thrombosis; Hepatic Portal Vein Tumor Invasion

Keywords

Hepatocellular Carcinoma; Thrombosis; Portal Vein Invasion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survival rate in years

  1 to 3 years

• Relation established between survival and degree of underlying liver dysfunction

  1 to 3 years

Study Arms (1)

Hepatocellular carcinoma underwent surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection with curative intent with the presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sírio-Libanês

São Paulo, Brazil

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Thrombosis

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; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 24, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 30, 2012
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

BR (1)