Accuracy of the LiverVision® Semi-automated Liver Volumetry Software

Liver Cancer Clinical Trial

— LiverVision  

Official title:

Accuracy of Established Manual Versus New Semi-automated Liver Volumetry Software in Patients Undergoing Living Donor Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766633
• Other study ID #: LV.2018.04.29
• Status: Recruiting
• Start date: April 29, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2020
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: Dimitri A Raptis, MD, MSc, PhD
• Phone: +447584560889
• Email: dimitri.raptis[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Recipients

Related Conditions & MeSH terms

• Liver Cancer
• Liver Diseases

Intervention

Diagnostic Test:
• Liver volumetry of the graft on CT
Preoperative liver volumetry using the CT images of the potential living liver donors.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Tübingen	Tübingen
Turkey	Ankara Üniversitesi Tip Fakültesi Cebeci Arastirma ve Uygulama Hastanesi	Ankara
United Kingdom	Royal Free Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
Royal Free Hospital NHS Foundation Trust	Ankara University, Imperial College Healthcare NHS Trust, University Hospital Tuebingen

Countries where clinical trial is conducted

Germany,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (CT performed prior to donation).
Secondary	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.	Baseline (CT performed prior to donation).
Secondary	Certainty and accuracy of the volumetric measurements.	Correlation of the degree of certainty of the raters with the accuracy of their volumetric measurements.	Baseline (CT performed prior to donation).
Secondary	Comparison	Comparison of the accuracy among junior, senior, surgeons and radiologists (4 groups)	Baseline (CT performed prior to donation).

External Links

•   Cloud Graphical User Interface for R Statistics, the statistical analysis software
•   Data management platform for the LiverVision.org Study