- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865612
A Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation
March 6, 2025 updated by: Chungnam National University Hospital
Optimizing Accuracy: a Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation from a Surgeon's Perspective
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is a retrospective diagnostic accuracy study comparing three liver volumetry methods using preoperative donor CT scans in LDLT.
Study Type
Observational
Enrollment (Actual)
109
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
-
-
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Daejeon, Korea, Republic of
- Chungnam National University Hospital
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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).
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients deemed unsuitable for participation in this clinical study by the investigator.
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
Cohorts and Interventions
Group / Cohort |
|---|
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Donors
Patients who received hepatectomy for the living donor liver transplantation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of preoperative estimated graft volume (EGV) compared to actual graft weight (AGW)
Time Frame: From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)
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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.
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From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of the optimal dry weight correction factor for each volumetry method
Time Frame: From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)
|
The study aims to determine the optimal dry weight correction factor by minimizing the discrepancy between EGV and AGW.
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From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
November 1, 2011
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
January 31, 2025
Study Registration Dates
First Submitted
March 6, 2025
First Submitted That Met QC Criteria
March 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 6, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-05-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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