- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387061
Resection for Multiple Hepatocellular Carcinomas (HCC)
September 18, 2011 updated by: Prof. Guido Torzilli, University of Milan
Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
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
-
-
MI
-
Rozzano, Milan, MI, Italy, 20089
- University of Milan IRCCS Istituto Clinico Humanitas
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with multiple HCC without macrovascular invasion on liver cirrhosis
Exclusion Criteria:
- macrovascular invasion;
- normal liver;
- distant or lymphnodes metastasis
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: hepatic resection
|
surgical resection of the liver for multiple HCC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease-free survival
Time Frame: 10 years
|
The secondary endpoint was the disease-free survival.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: GUIDO TORZILLI, MD, PHD, University of Milan
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
June 1, 2001
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 29, 2011
First Submitted That Met QC Criteria
July 1, 2011
First Posted (Estimate)
July 4, 2011
Study Record Updates
Last Update Posted (Estimate)
September 20, 2011
Last Update Submitted That Met QC Criteria
September 18, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- multipleHCC
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.