Hepatocellular CarcinomaNCT01387061
Resection for Multiple Hepatocellular Carcinomas (HCC)
A study testing hepatic resection in people with Hepatocellular Carcinoma and Multiple Tumors, run by University of Milan at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma, Multiple Tumors, Cirrhosis
- What is being tested?
- hepatic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2001to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with multiple HCC without macrovascular invasion on liver cirrhosis
Who cannot join
- macrovascular invasion;
- normal liver;
- distant or lymphnodes metastasis
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Milan IRCCS Istituto Clinico Humanitas
Rozzano, Milan, MI, 20089
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma, Multiple Tumors, Cirrhosis
- Being tested
- hepatic resection
- Keywords
- liver resection, hepatic resection, intraoperative ultrasound
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic resectionProcedure or surgery
surgical resection of the liver for multiple HCC
| Study group | Role | What they receive |
|---|---|---|
| hepatic resection | Experimental | Not described Receives: Procedure: hepatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
Disease-free survival
The secondary endpoint was the disease-free survival.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJun 2001
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
- Investigators
- Guido Torzilli, MD, PhD, Study chair, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387061
- Sponsor's protocol ID
- multipleHCC
- Status last verified
- Sep 2011
- First submitted
- 29 Jun 2011
- Last updated
- 20 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis
- ClinicalTrials.gov ID
- NCT01387061
- Acronym / sponsor ID
- multipleHCC
- Conditions
- Hepatocellular Carcinoma, Multiple Tumors, Cirrhosis
- Keywords
- liver resection, hepatic resection, intraoperative ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatic resection | Experimental | Procedure: hepatic resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with multiple HCC without macrovascular invasion on liver cirrhosis
Key exclusion criteria (3 listed)
- macrovascular invasion;
- normal liver;
- distant or lymphnodes metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatic resectionsurgical resection of the liver for multiple HCC | Procedure or surgery | hepatic resection |
Primary outcome
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.
1 secondary outcome
Disease-free survival
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Torzilli, MD, PhD study chair
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hepatic resection in people with Hepatocellular Carcinoma and Multiple Tumors, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival plus multivariate analysis (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.