Accuracy of the LiverVision® Semi-automated Liver Volumetry Software (LiverVision)

November 18, 2020 updated by: Dimitri Raptis, Royal Free Hospital NHS Foundation Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

108

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

  • Germany
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
  • Turkey
      • Ankara, Turkey, 06620
        • Recruiting
        • Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi
        • Contact:
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
        • Contact:
          • Massimo Malagò, MD, PhD

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Adults (18 years or older)
  • Living liver donors.

Exclusion Criteria:

  • Recipients

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Living liver donors
This is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient.
Diagnostic test: Liver volumetry of the graft on CT
Preoperative liver volumetry using the CT images of the potential living liver donors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (CT performed prior to donation).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning curve of the raters
Time Frame: Baseline (CT performed prior to donation).
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.
Baseline (CT performed prior to donation).
Certainty and accuracy of the volumetric measurements.
Time Frame: Baseline (CT performed prior to donation).
Correlation of the degree of certainty of the raters with the accuracy of their volumetric measurements.
Baseline (CT performed prior to donation).
Comparison
Time Frame: Baseline (CT performed prior to donation).
Comparison of the accuracy among junior, senior, surgeons and radiologists (4 groups)
Baseline (CT performed prior to donation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Free Hospital NHS Foundation Trust

Collaborators

University Hospital Tuebingen
Imperial College Healthcare NHS Trust
Ankara University

Investigators

  • Principal Investigator: Massimo Malago', MD, PhD, Royal Free Hospital NHS Foundation Trust

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.

Helpful Links

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 (Actual)

April 29, 2018

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LV.2018.04.29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan for sharing individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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