Back to resultsPrognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC (ARversusNAR)
Primary Purpose
Patients Affected by Hepatocellular Carcinoma, Disease-Free Survival, Overall Survival
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
anatomical liver resection
Non-anatomical liver resection
Sponsored by
About this trial
This is an interventional treatment trial for Patients Affected by Hepatocellular Carcinoma focused on measuring anatomical resection, non-anatomical resection, IOUS-guided finger compression
Eligibility Criteria
Inclusion Criteria:
- patient affected by single HCC
- patients in whom liver resection is indicated
- HCC without vascular invasion and/or thrombosis
Exclusion Criteria:
- multinodular HCC
- metastatic disease
- spontaneous tumor rupture
Sites / Locations
- IRCCS Istituto Clinico Humanitas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anatomical resection
Non-anatomical resection
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01236989
Brief Title
Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC
Acronym
ARversusNAR
Official Title
Anatomical Liver Resection by Means of Ultrasound-guided Vessel Compression Versus Non-anatomical Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Milan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prognostic impact of AR vs NAR
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Affected by Hepatocellular Carcinoma, Disease-Free Survival, Overall Survival
Keywords
anatomical resection, non-anatomical resection, IOUS-guided finger compression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anatomical resection
Arm Type
Experimental
Arm Title
Non-anatomical resection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
anatomical liver resection
Intervention Description
anatomical liver resection by means of IOUS-finger compression
Intervention Type
Procedure
Intervention Name(s)
Non-anatomical liver resection
Intervention Description
non-anatomical liver resection
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility
Time Frame
30 and 90 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient affected by single HCC
patients in whom liver resection is indicated
HCC without vascular invasion and/or thrombosis
Exclusion Criteria:
multinodular HCC
metastatic disease
spontaneous tumor rupture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guido Torzilli, MD, PhD
Phone
+39 02 8224
Ext
4083
Email
guido.torzilli@unimi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Torzilli, MD, PhD
Organizational Affiliation
IRCCS Istituto Clinico Humanitas, Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Torzilli, MD, PhD
Phone
+39 02 8224
Ext
4083
Email
guido.torzilli@unimi.it
First Name & Middle Initial & Last Name & Degree
Guido Torzilli, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16041216
Citation
Hasegawa K, Kokudo N, Imamura H, Matsuyama Y, Aoki T, Minagawa M, Sano K, Sugawara Y, Takayama T, Makuuchi M. Prognostic impact of anatomic resection for hepatocellular carcinoma. Ann Surg. 2005 Aug;242(2):252-9. doi: 10.1097/01.sla.0000171307.37401.db.
Results Reference
background
PubMed Identifier
19838106
Citation
Torzilli G, Procopio F, Cimino M, Del Fabbro D, Palmisano A, Donadon M, Montorsi M. Anatomical segmental and subsegmental resection of the liver for hepatocellular carcinoma: a new approach by means of ultrasound-guided vessel compression. Ann Surg. 2010 Feb;251(2):229-35. doi: 10.1097/SLA.0b013e3181b7fdcd.
Results Reference
background
PubMed Identifier
14625736
Citation
Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. doi: 10.1007/s00464-003-9024-x. Epub 2003 Nov 21.
Results Reference
background
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Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC
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