Liver DiseasesLiverVisionNCT03766633
Accuracy of the LiverVision® Semi-automated Liver Volumetry Software
An observational study of Liver Diseases and Liver Cancer, run by Royal Free Hospital NHS Foundation Trust at 3 sites in 3 countries.
Trial summary
The LiverVision® software was designed to provide three-dimensional (3D) visualisation of the liver using Computed Tomography (CT) scans. It provides semi-automated volumetry measurements, vascular structure and territory tools. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Liver Cancer
- What is being tested?
- Liver volumetry of the graft on CT
- How many people
- 108 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 29 Apr 2018to 31 Mar 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive living liver donors that underwent a CT prior to liver donation. The raters will be 6 surgeons and 6 radiologists, both junior and senior.
Who may be able to join
- Adults (18 years or older)
- Living liver donors.
Who cannot join
- Recipients
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Arnold Radke, MD, PhD, +497071290, arnoldradke@yahoo.de
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi
Ankara, 06620
Deniz Balci, MD, +903125956000, denizbalci1@yahoo.com
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital
London, NW3 2QG
Massimo Malagò, MD, PhD
Dimitri A Raptis, MD, MSc, PhD, +447584560889, dimitri.raptis@nhs.net
About this study
Official title: Accuracy of Established Manual Versus New Semi-automated Liver Volumetry Software in Patients Undergoing Living Donor Liver Transplantation
The LiverVision® software was designed to provide three-dimensional (3D) visualisation of the liver using Computed Tomography (CT) scans. It provides semi-automated volumetry measurements, vascular structure and territory tools.
Read the detailed description
Liver volumetry has been widely used in liver surgery and living donor liver transplantation to estimate the future liver remnant or the required liver volume for the recipient, respectively.
Liver volumetry is typically performed using CT imaging with specially designed software. Such manual measurements are time consuming and there is an ongoing debate whether the they reflect the actual liver volume when performed by radiologists or surgeons as well as according to the different software currently available in the market.
- Conditions
- Liver Diseases, Liver Cancer
- Being tested
- Liver volumetry of the graft on CT
- Keywords
- LiverVision, Liver, Volumetry, Semi-automated, Living donor liver transplantation, Surgery
- Medical subject headings
- Liver Diseases, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver volumetry of the graft on CTDiagnostic test
Preoperative liver volumetry using the CT images of the potential living liver donors.
| Study group | Role | What they receive |
|---|---|---|
| Living liver donors | This is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient. Receives: Diagnostic Test: Liver volumetry of the graft on CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the LiverVision® software volumetric measurements
Accuracy of the LiverVision® software volumetric measurements assessed by correlation and agreement statistics with the manual volumetric measurements as well as the actual graph weight (reference standard).
Measured: Baseline (CT performed prior to donation).
Secondary outcomes (3)
Learning curve of the raters
Assessment of the learning curve of the raters when using LiverVision® software assessed by the time required for the volumetric measurements and the accuracy of the results.
Measured: Baseline (CT performed prior to donation).
Certainty and accuracy of the volumetric measurements.
Correlation of the degree of certainty of the raters with the accuracy of their volumetric measurements.
Measured: Baseline (CT performed prior to donation).
Comparison
Comparison of the accuracy among junior, senior, surgeons and radiologists (4 groups)
Measured: Baseline (CT performed prior to donation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start29 Apr 2018
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University, University Hospital Tuebingen, Imperial College Healthcare NHS Trust
- Responsible party
- Principal investigator, Dimitri Raptis, Royal Free Hospital NHS Foundation Trust
- Investigators
- Massimo Malago', MD, PhD, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766633
- Sponsor's protocol ID
- LV.2018.04.29
- Acronym
- LiverVision
- Status last verified
- Nov 2020
- First submitted
- 4 Dec 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for sharing individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Established Manual Versus New Semi-automated Liver Volumetry Software in Patients Undergoing Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT03766633
- Acronym / sponsor ID
- LiverVision / LV.2018.04.29
- Conditions
- Liver Diseases, Liver Cancer
- Keywords
- LiverVision, Liver, Volumetry, Semi-automated, Living donor liver transplantation, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Ankara University, University Hospital Tuebingen, Imperial College Healthcare NHS Trust
- Study start
- 29 Apr 2018 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 6 Dec 2018 (actual)
- 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.
The LiverVision® software was designed to provide three-dimensional (3D) visualisation of the liver using Computed Tomography (CT) scans. It provides semi-automated volumetry measurements, vascular structure and territory tools.
Detailed description
Liver volumetry has been widely used in liver surgery and living donor liver transplantation to estimate the future liver remnant or the required liver volume for the recipient, respectively.
Liver volumetry is typically performed using CT imaging with specially designed software. Such manual measurements are time consuming and there is an ongoing debate whether the they reflect the actual liver volume when performed by radiologists or surgeons as well as according to the different software currently available in the market.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living liver donors | – | Diagnostic Test: Liver volumetry of the graft on CTThis is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive living liver donors that underwent a CT prior to liver donation. The raters will be 6 surgeons and 6 radiologists, both junior and senior.
Key inclusion criteria (2 listed)
- Adults (18 years or older)
- Living liver donors.
Key exclusion criteria (1 listed)
- Recipients
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 |
|---|---|---|
| Liver volumetry of the graft on CTPreoperative liver volumetry using the CT images of the potential living liver donors. | Diagnostic test | Living liver donors |
Primary outcome
Accuracy of the LiverVision® software volumetric measurements
Time frame: Baseline (CT performed prior to donation).
Accuracy of the LiverVision® software volumetric measurements assessed by correlation and agreement statistics with the manual volumetric measurements as well as the actual graph weight (reference standard).
3 secondary outcomes
Learning curve of the raters
Time frame: Baseline (CT performed prior to donation).
Certainty and accuracy of the volumetric measurements.
Time frame: Baseline (CT performed prior to donation).
Comparison
Time frame: Baseline (CT performed prior to donation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Data management platform for the LiverVision.org StudyLink provided by the sponsor.
- The official website of the LiverVision® software, currently under developmentLink provided by the sponsor.
- Cloud Graphical User Interface for R Statistics, the statistical analysis softwareLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan for sharing individual participant data.
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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.
Massimo Malago', MD, PhD principal investigator
Royal Free Hospital NHS Foundation Trust
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Cancer, run by Royal Free Hospital NHS Foundation Trust at 3 sites in 3 countries.
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 2 inclusion and 1 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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Turkey (Türkiye), United Kingdom. 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 Dimitri A Raptis, MD, MSc, PhD (+447584560889, dimitri.raptis@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the LiverVision® software volumetric measurements (time frame: Baseline (CT performed prior to donation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2020.