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Resection for Multiple Hepatocellular Carcinomas (HCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan
ClinicalTrials.gov Identifier:
NCT01387061
First received: June 29, 2011
Last updated: September 18, 2011
Last verified: September 2011
  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: 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 University of Milan:

Primary Outcome Measures:
  • Overall survival plus multivariate analysis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
ClinicalTrials.gov Identifier: NCT01387061     History of Changes
Other Study ID Numbers: multipleHCC
Study First Received: June 29, 2011
Last Updated: September 18, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by University of Milan:
liver resection
hepatic resection
intraoperative ultrasound

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

ClinicalTrials.gov processed this record on November 27, 2014