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Resection for Multiple Hepatocellular Carcinomas (HCC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01387061
First Posted: July 4, 2011
Last Update Posted: September 20, 2011
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):
Prof. Guido Torzilli, University of Milan
  Purpose
Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains controversial. The aim of this study was to investigate the outcome of a consecutive cohort of patients resected for multiple HCC, without macrovascular invasion, in order to identify clinically reliable parameters to select patients for surgery.

Condition Intervention
Hepatocellular Carcinoma Multiple Tumors Cirrhosis Procedure: hepatic resection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis

Resource links provided by NLM:


Further study details as provided by Prof. Guido Torzilli, University of Milan:

Primary Outcome Measures:
  • Overall survival plus multivariate analysis [ Time Frame: 10 years ]
    The primary endpoint of the study was the overall survival of patients resected for multiple HCC, and the univariate and multivariate analyses of prognostic factors for overall survival.


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 10 years ]
    The secondary endpoint was the disease-free survival.


Enrollment: 87
Study Start Date: June 2001
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hepatic resection Procedure: hepatic resection
surgical resection of the liver for multiple HCC

  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
Criteria

Inclusion Criteria:

  • patients with multiple HCC without macrovascular invasion on liver cirrhosis

Exclusion Criteria:

  • macrovascular invasion;
  • normal liver;
  • distant or lymphnodes metastasis
  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): NCT01387061


Locations
Italy
University of Milan IRCCS Istituto Clinico Humanitas
Rozzano, Milan, MI, Italy, 20089
Sponsors and Collaborators
University of Milan
Investigators
Study Chair: Guido Torzilli, MD, PhD University of Milan
  More Information

Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
ClinicalTrials.gov Identifier: NCT01387061     History of Changes
Other Study ID Numbers: multipleHCC
First Submitted: June 29, 2011
First Posted: July 4, 2011
Last Update Posted: September 20, 2011
Last Verified: September 2011

Keywords provided by Prof. Guido Torzilli, University of Milan:
liver resection
hepatic resection
intraoperative ultrasound

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Fibrosis
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes