NCT06865612

Brief Summary

Accurate preoperative graft volume assessment is crucial for successful living donor liver transplantation (LDLT). Although manual and automated computed tomography (CT) volume measurement methods using various volumetric tools are widely used, their accuracy remains uncertain. This study aimed to determine the optimal dry weight correction factor for each method to enhance the prediction of actual graft weight (AGW) and compare the accuracy of different methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

February 1, 2025

Enrollment Period

13.2 years

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of preoperative estimated graft volume (EGV) compared to actual graft weight (AGW)

    The accuracy of preoperative donor CT liver volumetry will be assessed by comparing estimated graft volume (EGV) obtained from three methods (automated, semi-automated, manual) with the actual graft weight (AGW) measured intraoperatively. The error ratio between EGV and AGW will be calculated for each method.

    From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)

Secondary Outcomes (1)

  • Determination of the optimal dry weight correction factor for each volumetry method

    From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)

Study Arms (1)

Donors

Patients who received hepatectomy for the living donor liver transplantation.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes patients who underwent hepatectomy for living donor liver transplantation performed at Chungnam National University Hospital. Data will be retrospectively reviewed to compare preoperative estimated graft volume (EGV) to actual graft weight (AGW).

You may qualify if:

  • Patients who underwent hepatectomy for living donor liver transplantation performed by the Department of Surgery at Chungnam National University Hospital under the supervision of the principal investigator.

You may not qualify if:

  • Patients deemed unsuitable for participation in this clinical study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 10, 2025

Study Start

November 1, 2011

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

March 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.

Locations