Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC (ARversusNAR)
November 8, 2010 updated by: University of Milan
Anatomical Liver Resection by Means of Ultrasound-guided Vessel Compression Versus Non-anatomical Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
Prognostic impact of AR vs NAR
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
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
-
-
Milan
-
Rozzano, Milan, Italy, 20089
- 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:
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anatomical resection
|
anatomical liver resection by means of IOUS-finger compression
|
|
Active Comparator: Non-anatomical resection
|
non-anatomical liver resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
5-years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility
Time Frame: 30 and 90 days
|
30 and 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guido Torzilli, MD, PhD, IRCCS Istituto Clinico Humanitas, Milan, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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
January 1, 2011
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
October 29, 2010
First Submitted That Met QC Criteria
November 8, 2010
First Posted (Estimate)
November 9, 2010
Study Record Updates
Last Update Posted (Estimate)
November 9, 2010
Last Update Submitted That Met QC Criteria
November 8, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AR vs NAR
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