Patients Affected by Hepatocellular CarcinomaARversusNARNCT01236989
Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC
A study testing anatomical liver resection and Non-anatomical liver resection in people with Patients Affected by Hepatocellular Carcinoma and Disease-Free Survival, run by University of Milan at 1 site in Italy.
Trial summary
Prognostic impact of AR vs NAR Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Affected by Hepatocellular Carcinoma, Disease-Free Survival, Overall Survival
- What is being tested?
- anatomical liver resection and Non-anatomical liver resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient affected by single HCC
- patients in whom liver resection is indicated
- HCC without vascular invasion and/or thrombosis
Who cannot join
- multinodular HCC
- metastatic disease
- spontaneous tumor rupture
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Clinico Humanitas
Rozzano, Milan, 20089
Guido Torzilli, MD, PhD, +39 02 8224 ext. 4083, guido.torzilli@unimi.it
Guido Torzilli, MD, PhD
About this study
Official title: 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
Read the 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.
- Being tested
- anatomical liver resection, Non-anatomical liver resection
- Keywords
- anatomical resection, non-anatomical resection, IOUS-guided finger compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anatomical liver resectionProcedure or surgery
anatomical liver resection by means of IOUS-finger compression
Non-anatomical liver resectionProcedure or surgery
non-anatomical liver resection
| Study group | Role | What they receive |
|---|---|---|
| Anatomical resection | Experimental | Not described Receives: Procedure: anatomical liver resection |
| Non-anatomical resection | Active comparator | Not described Receives: Procedure: Non-anatomical liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5-years
Secondary outcomes (1)
the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients Affected by Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- Guido Torzilli, MD, PhD, Principal investigator, IRCCS Istituto Clinico Humanitas, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236989
- Sponsor's protocol ID
- AR vs NAR
- Acronym
- ARversusNAR
- Status last verified
- Oct 2010
- First submitted
- 29 Oct 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16041216Torzilli 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.
PubMed 19838106Torzilli 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.
PubMed 14625736
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Liver Resection by Means of Ultrasound-guided Vessel Compression Versus Non-anatomical Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01236989
- Acronym / sponsor ID
- ARversusNAR / AR vs NAR
- Keywords
- anatomical resection, non-anatomical resection, IOUS-guided finger compression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomical resection | Experimental | Procedure: anatomical liver resection |
| Non-anatomical resection | Active comparator | Procedure: Non-anatomical liver resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patient affected by single HCC
- patients in whom liver resection is indicated
- HCC without vascular invasion and/or thrombosis
Key exclusion criteria (3 listed)
- multinodular HCC
- metastatic disease
- spontaneous tumor rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anatomical liver resectionanatomical liver resection by means of IOUS-finger compression | Procedure or surgery | Anatomical resection |
| Non-anatomical liver resectionnon-anatomical liver resection | Procedure or surgery | Non-anatomical resection |
Primary outcome
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
1 secondary outcome
the impact of anatomical resection versus non-anatomical resection in terms of postoperative mortality and morbility
Time frame: 30 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 16041216Hasegawa 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.
- Background: PubMed 19838106Torzilli 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.
- Background: PubMed 14625736Torzilli 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Torzilli, MD, PhD principal investigator
IRCCS Istituto Clinico Humanitas, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anatomical liver resection and Non-anatomical liver resection in people with Patients Affected by Hepatocellular Carcinoma and Disease-Free Survival, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guido Torzilli, MD, PhD (+39 02 8224 ext. 4083, guido.torzilli@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236989, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.