Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC
ARversusNAR
Anatomical Liver Resection by Means of Ultrasound-guided Vessel Compression Versus Non-anatomical Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
Prognostic impact of AR vs NAR
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 9, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 9, 2010
October 1, 2010
6.9 years
October 29, 2010
November 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
5-years
Secondary Outcomes (1)
the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility
30 and 90 days
Study Arms (2)
Anatomical resection
EXPERIMENTALNon-anatomical resection
ACTIVE COMPARATORInterventions
anatomical liver resection by means of IOUS-finger compression
Eligibility Criteria
You may qualify if:
- patient affected by single HCC
- patients in whom liver resection is indicated
- HCC without vascular invasion and/or thrombosis
You may not qualify if:
- multinodular HCC
- metastatic disease
- spontaneous tumor rupture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Istituto Clinico Humanitas
Rozzano, Milan, 20089, Italy
Related Publications (3)
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.
PMID: 16041216BACKGROUNDTorzilli 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.
PMID: 19838106BACKGROUNDTorzilli 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.
PMID: 14625736BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Guido Torzilli, MD, PhD
IRCCS Istituto Clinico Humanitas, Milan, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 9, 2010
Study Start
January 1, 2011
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
November 9, 2010
Record last verified: 2010-10