Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery (HSL2012-06)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hospital Sirio-Libanes
Sponsor:
Information provided by (Responsible Party):
Frederico Perego Costa, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT01690715
First received: September 12, 2012
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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.


Condition
Hepatocellular Carcinoma
Portal Vein Thrombosis
Hepatic Portal Vein Tumor Invasion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery

Resource links provided by NLM:


Further study details as provided by Hospital Sirio-Libanes:

Primary Outcome Measures:
  • Prognosis (disease graduation) [ Time Frame: 1 to 3 years ] [ Designated as safety issue: Yes ]
    The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis.


Secondary Outcome Measures:
  • Survival rate in years [ Time Frame: 1 to 3 years ] [ Designated as safety issue: Yes ]
    Determination of the survival rate within 1 to 3 years for those submitted to curative hepatectomy.

  • Relation established between survival and degree of underlying liver dysfunction [ Time Frame: 1 to 3 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: July 2012
Groups/Cohorts
Hepatocellular carcinoma underwent surgery

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690715

Contacts
Contact: Frederico Costa 55 11 3155 8800 frederico.costa@hsl.org.br

Locations
Brazil
Hospital Sírio-Libanês Recruiting
São Paulo, Brazil
Contact: Frederico Costa    55 11 3155 8800      
Principal Investigator: Frederico Costa, Md         
Sponsors and Collaborators
Hospital Sirio-Libanes
  More Information

No publications provided

Responsible Party: Frederico Perego Costa, Attending physician, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT01690715     History of Changes
Other Study ID Numbers: HSL 2012/06
Study First Received: September 12, 2012
Last Updated: September 19, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Sirio-Libanes:
Hepatocellular Carcinoma
Thrombosis
Portal Vein Invasion

Additional relevant MeSH terms:
Carcinoma
Thrombosis
Venous Thrombosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 23, 2014