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

November 21, 2023 updated by: Frederico Perego Costa, Hospital Sirio-Libanes
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Hospital Sírio-Libanês

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Hepatocellular carcinoma underwent surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 3 years
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.
1 to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 30, 2012

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimated)

September 24, 2012

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSL 2012/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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