Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC (ARversusNAR)
This study is not yet open for participant recruitment.
Verified October 2010 by University of Milan
Sponsor:
University of Milan
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT01236989
First received: October 29, 2010
Last updated: November 8, 2010
Last verified: October 2010
| Tracking Information | |||||
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| First Received Date ICMJE | October 29, 2010 | ||||
| Last Updated Date | November 8, 2010 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | December 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
the prognostic impact of anatomical resection by means of intraoperative ultrasound (IOUS) guided vessel compression versus nonanatomical resection in terms of disease free and overall survival [ Time Frame: 5-years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01236989 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility [ Time Frame: 30 and 90 days ] [ Designated as safety issue: Yes ] | ||||
| 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 | Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC | ||||
| Official Title ICMJE | Anatomical Liver Resection by Means of Ultrasound-guided Vessel Compression Versus Non-anatomical Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial | ||||
| Brief Summary | Prognostic impact of AR vs NAR |
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| Detailed Description | Whether anatomical is better than non anatomical resection for HCC is still debated. This prospective randomized study aimed to address which approach is better in terms of patients prognosis. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | December 2017 | ||||
| Estimated Primary Completion Date | December 2017 (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 |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01236989 | ||||
| Other Study ID Numbers ICMJE | AR vs NAR | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Guido Torzilli, MD, PhD, Liver Surgery Unit, 3rd Department of Surgery, University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas, Rozzano, Milan, Italy | ||||
| Study Sponsor ICMJE | University of Milan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Milan | ||||
| Verification Date | October 2010 | ||||
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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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