Resection for Multiple Hepatocellular Carcinomas (HCC)
This study has been completed.
Sponsor:
University of Milan
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
| Tracking Information | |||||
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| First Received Date ICMJE | June 29, 2011 | ||||
| Last Updated Date | September 18, 2011 | ||||
| Start Date ICMJE | June 2001 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01387061 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Disease-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ] The secondary endpoint was the disease-free survival. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Resection for Multiple Hepatocellular Carcinomas (HCC) | ||||
| Official Title ICMJE | Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: hepatic resection
surgical resection of the liver for multiple HCC |
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| Study Arm (s) | Experimental: hepatic resection
Intervention: Procedure: hepatic resection |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 87 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01387061 | ||||
| Other Study ID Numbers ICMJE | multipleHCC | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Prof. Guido Torzilli, University of Milan | ||||
| Study Sponsor ICMJE | University of Milan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Milan | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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