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Resection for Multiple Hepatocellular Carcinomas (HCC)

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ClinicalTrials.gov Identifier: NCT01387061
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan

Brief Summary:
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 or disease Intervention/treatment
Hepatocellular Carcinoma Multiple Tumors Cirrhosis Procedure: hepatic resection

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis
Study Start Date : June 2001
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: hepatic resection Procedure: hepatic resection
surgical resection of the liver for multiple HCC

Primary Outcome Measures :
  1. 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 :
  1. Disease-free survival [ Time Frame: 10 years ]
    The secondary endpoint was the disease-free survival.

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

Inclusion Criteria:

  • patients with multiple HCC without macrovascular invasion on liver cirrhosis

Exclusion Criteria:

  • macrovascular invasion;
  • normal liver;
  • distant or lymphnodes metastasis

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

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

Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
ClinicalTrials.gov Identifier: NCT01387061     History of Changes
Other Study ID Numbers: multipleHCC
First Posted: July 4, 2011    Key Record Dates
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, Hepatocellular
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes