Back to resultsResection for Multiple Hepatocellular Carcinomas (HCC)
Primary Purpose
Hepatocellular Carcinoma, Multiple Tumors, Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hepatic resection
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring liver resection, hepatic resection, intraoperative ultrasound
Eligibility Criteria
Inclusion Criteria:
- patients with multiple HCC without macrovascular invasion on liver cirrhosis
Exclusion Criteria:
- macrovascular invasion;
- normal liver;
- distant or lymphnodes metastasis
Sites / Locations
- University of Milan IRCCS Istituto Clinico Humanitas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hepatic resection
Arm Description
Outcomes
Primary Outcome Measures
Overall survival plus multivariate analysis
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
The secondary endpoint was the disease-free survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01387061
Brief Title
Resection for Multiple Hepatocellular Carcinomas (HCC)
Official Title
Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Multiple Tumors, Cirrhosis
Keywords
liver resection, hepatic resection, intraoperative ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hepatic resection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
hepatic resection
Intervention Description
surgical resection of the liver for multiple HCC
Primary Outcome Measure Information:
Title
Overall survival plus multivariate analysis
Description
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.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
The secondary endpoint was the disease-free survival.
Time Frame
10 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with multiple HCC without macrovascular invasion on liver cirrhosis
Exclusion Criteria:
macrovascular invasion;
normal liver;
distant or lymphnodes metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Torzilli, MD, PhD
Organizational Affiliation
University of Milan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Milan IRCCS Istituto Clinico Humanitas
City
Rozzano, Milan
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Resection for Multiple Hepatocellular Carcinomas (HCC)
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