Accuracy of the LiverVision® Semi-automated Liver Volumetry Software

• Conditions: Liver Diseases; Liver Cancer
• Interventions: Diagnostic Test: Liver volumetry of the graft on CT

• Registration Number: NCT03766633
• Lead Sponsor: Royal Free Hospital NHS Foundation Trust

Brief 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.

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 Timeline

• Study Start: 2018-04-29
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

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

Exclusion Criteria

• Recipients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Living liver donors	Liver volumetry of the graft on CT	This is a group of living liver donors that underwent a CT prior to donating their partial liver to a recipient.

Primary Outcome Measures

Name	Time	Method
Accuracy of the LiverVision® software volumetric measurements	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).

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Royal Free Hospital; 🇬🇧 London, United Kingdom

Ankara Üniversitesi Tıp Fakültesi Cebeci Araştırma ve Uygulama Hastanesi; 🇹🇷 Ankara, Turkey

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany