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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Frederico Perego Costa, Hospital Sirio-Libanes.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690715
First Posted: September 24, 2012
Last Update Posted: September 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frederico Perego Costa, Hospital Sirio-Libanes
  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 Frederico Perego Costa, Hospital Sirio-Libanes:

Primary Outcome Measures:
  • Prognosis (disease graduation) [ Time Frame: 1 to 3 years ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Frederico Perego Costa, Attending physician, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT01690715     History of Changes
Other Study ID Numbers: HSL 2012/06
First Submitted: September 12, 2012
First Posted: September 24, 2012
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by Frederico Perego Costa, Hospital Sirio-Libanes:
Hepatocellular Carcinoma
Thrombosis
Portal Vein Invasion

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