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

Conditions

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

  • Italy
    • 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
Procedure: anatomical liver resection
anatomical liver resection by means of IOUS-finger compression
Active Comparator: Non-anatomical resection
Procedure: Non-anatomical liver 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

University of Milan

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

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR vs NAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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