Living Donor Liver TransplantationNCT06865612
A Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation
An observational study of Living Donor Liver Transplantation and Liver Failure, run by Chungnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Living Donor Liver Transplantation, Liver Failure
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2011to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Patients deemed unsuitable for participation in this clinical study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This study is a retrospective diagnostic accuracy study comparing three liver volumetry methods using preoperative donor CT scans in LDLT.
- Conditions
- Living Donor Liver Transplantation, Liver Failure
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Donors | Patients who received hepatectomy for the living donor liver transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The study aims to determine the optimal dry weight correction factor by minimizing the discrepancy between EGV and AGW.
Measured: From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Nov 2011
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865612
- Sponsor's protocol ID
- 2024-05-025
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Accuracy: a Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation from a Surgeon's Perspective
- ClinicalTrials.gov ID
- NCT06865612
- Acronym / sponsor ID
- 2024-05-025
- Conditions
- Living Donor Liver Transplantation, Liver Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a retrospective diagnostic accuracy study comparing three liver volumetry methods using preoperative donor CT scans in LDLT.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donors | – | –Patients who received hepatectomy for the living donor liver transplantation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients deemed unsuitable for participation in this clinical study by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No. The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.
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The Regenerative Capacity of the Donor Liver After Living Donor Liver Transplantation: an Ambidirectional Cohort Study
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Longitudinal Follow-up and Health-Related Outcomes in Liver Transplant Recipients and Living Donors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Living Donor Liver Transplantation and Liver Failure, run by Chungnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.