Non-invasive Donor Liver AssessmentDonorFibroScanNCT07451379
Comparison of Liver Biopsy Versus Fibroscan With CAP ( Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
An observational study of Non-invasive Donor Liver Assessment, run by Assiut University.
Trial summary
In our study we aiming that liver biopsy histological analysis as a reference standard, to examine the precision of fbroscan controlled attenuation parameter (CAP) for quantitative evaluation of macrovesicular steatosis in living related liver donors. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-invasive Donor Liver Assessment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: * After obtaining the appropriate consents, data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake). * blood samples will be collected for CBC. ( Hb level , WBCs, Platelets), liver function tests (albumin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase, total bilirubin), lipid profile (total cholesterol, triglyceride, LDL), CRP, serum uric acid, HbA1c, and Kidney function test(serum urea and creatinine). * Six measurements will be obtained (sex, age, height, weight, body mass index, and waist circumference). Overweight is defined as BMI ≥25 kg/m² and obesity is defined as: BMI ≥30 kg/m². * Imaging for evaluation of donors with BMI ≥25 kg/m² such as abdominal US and FibroScan with CAP. * Donors with BMI ≥25 kg/m² will receive life style modification and medical treatment for improvement of steatosis
Who may be able to join
- All donors aged >18 years old
- eligible for Liver Transplant
Who cannot join
- -Subjects aged ≤18 years old.
- Donors refused to do FibroScan with CAP
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Liver Biopsy Versus Fibroscan With CAP (Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
In our study we aiming that liver biopsy histological analysis as a reference standard, to examine the precision of fbroscan controlled attenuation parameter (CAP) for quantitative evaluation of macrovesicular steatosis in living related liver donors.
Read the detailed description
To reduce waitlist mortality in living donor liver transplantation (LDLT) there are ongoing efforts to expand the living liver donor pool. Simultaneously, the prevalence of nonalcoholic fatty liver disease (NAFLD) in the general population has increased from 15% to 25% since 2005, which has significant implications on the pool of potential living liver donors.
Hepatic steatosis is one of the most frequent chronic parenchymatous liver changes in healthy people, and it can prevent a healthy donor from transplantation, because fatty changes that affect the graft's longevity can also affect the donor's own liver function.
The liver biopsy is the most crucial procedure for the identification and measurement of hepatic steatosis. Nevertheless, this approach is still invasive and exposes users to the danger of bleeding and infection, and is frequently only performed on carefully chosen donors and is not appropriate for screening or tracking.
The controlled attenuation parameter (CAP) using fbroscan M or XL probe has been created for hepatic steatosis evaluation. In individuals with non-alcoholic fatty liver disease (NAFLD), moderate steatosis has been shown to respond favourably to CAP.
Due to the limitations of biopsy, many noninvasive methods, particularly radiological methods for the assessment of steatosis, have emerged. These methods include CAP, US assessment, CT, magnetic reso-nance imaging (MRI), and liver stiffness measurements (LSMs) based on US signal.
Numerous benefits of the CAP determined by TE, such as its noninvasive, non ionizing, quantitative, quick, and repeatable characteristics, indicate that this parameter may be an effective method for identifying prospective living liver transplants.The CAP determined by TE has been used in numerous but small investigations to assess hepatic steatosis in living liver donations.
The efectiveness of CAP for identifying steatosis in 55 living liver donation prospects was assessed. They discovered that using US-guided liver biopsy as the reference standard, the AUROC ( Area Under the Receiver Operating Characteristic Curve) of CAP for detecting complete steatosis (>33%) was 0.88 with a cutoff value of 276 dB/m. Fifty-four living donors were evaluated using the CAP in a different research , and the outcomes were compared with those from intra-operative biopsy. With a cutoff value of 257 dB/m in that research, the CAP had an AUROC of 0.96 for identifying complete steatosis (>5%).
In a different study in 204 living donors were evaluated using CAP measurement and compared to the histological results for biopsy with only Mas being taken into account and MiS being excluded from the study. It was found that CAP had an AUROC of 0.938 for MaS 10% with a sensitivity of 84.2% and a specifcity of 92.4%.
- Conditions
- Non-invasive Donor Liver Assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of FibroScan Controlled Attenuation Parameter (CAP) for Quantitative Assessment of Macrovesicular Steatosis in Living Liver Donors: A Comparative Study with Liver Biopsy
This study aims to evaluate the diagnostic accuracy of FibroScan Controlled Attenuation Parameter (CAP) for the quantitative assessment of macrovesicular hepatic steatosis in living related liver donors, using liver biopsy histopathological analysis as the reference standard
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive Donor Liver AssessmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451379
- Sponsor's protocol ID
- 04-2026-300794
- Acronym
- DonorFibroScan
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Liver Biopsy Versus Fibroscan With CAP (Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
- ClinicalTrials.gov ID
- NCT07451379
- Acronym / sponsor ID
- DonorFibroScan / 04-2026-300794
- Conditions
- Non-invasive Donor Liver Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 Mar 2026 (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.
In our study we aiming that liver biopsy histological analysis as a reference standard, to examine the precision of fbroscan controlled attenuation parameter (CAP) for quantitative evaluation of macrovesicular steatosis in living related liver donors.
Detailed description
To reduce waitlist mortality in living donor liver transplantation (LDLT) there are ongoing efforts to expand the living liver donor pool. Simultaneously, the prevalence of nonalcoholic fatty liver disease (NAFLD) in the general population has increased from 15% to 25% since 2005, which has significant implications on the pool of potential living liver donors.
Hepatic steatosis is one of the most frequent chronic parenchymatous liver changes in healthy people, and it can prevent a healthy donor from transplantation, because fatty changes that affect the graft's longevity can also affect the donor's own liver function.
The liver biopsy is the most crucial procedure for the identification and measurement of hepatic steatosis. Nevertheless, this approach is still invasive and exposes users to the danger of bleeding and infection, and is frequently only performed on carefully chosen donors and is not appropriate for screening or tracking.
The controlled attenuation parameter (CAP) using fbroscan M or XL probe has been created for hepatic steatosis evaluation. In individuals with non-alcoholic fatty liver disease (NAFLD), moderate steatosis has been shown to respond favourably to CAP.
Due to the limitations of biopsy, many noninvasive methods, particularly radiological methods for the assessment of steatosis, have emerged. These methods include CAP, US assessment, CT, magnetic reso-nance imaging (MRI), and liver stiffness measurements (LSMs) based on US signal.
Numerous benefits of the CAP determined by TE, such as its noninvasive, non ionizing, quantitative, quick, and repeatable characteristics, indicate that this parameter may be an effective method for identifying prospective living liver transplants.The CAP determined by TE has been used in numerous but small investigations to assess hepatic steatosis in living liver donations.
The efectiveness of CAP for identifying steatosis in 55 living liver donation prospects was assessed. They discovered that using US-guided liver biopsy as the reference standard, the AUROC ( Area Under the Receiver Operating Characteristic Curve) of CAP for detecting complete steatosis (>33%) was 0.88 with a cutoff value of 276 dB/m. Fifty-four living donors were evaluated using the CAP in a different research , and the outcomes were compared with those from intra-operative biopsy. With a cutoff value of 257 dB/m in that research, the CAP had an AUROC of 0.96 for identifying complete steatosis (>5%).
In a different study in 204 living donors were evaluated using CAP measurement and compared to the histological results for biopsy with only Mas being taken into account and MiS being excluded from the study. It was found that CAP had an AUROC of 0.938 for MaS 10% with a sensitivity of 84.2% and a specifcity of 92.4%.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- * After obtaining the appropriate consents, data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake). * blood samples will be collected for CBC. ( Hb level , WBCs, Platelets), liver function tests (albumin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase, total bilirubin), lipid profile (total cholesterol, triglyceride, LDL), CRP, serum uric acid, HbA1c, and Kidney function test(serum urea and creatinine). * Six measurements will be obtained (sex, age, height, weight, body mass index, and waist circumference). Overweight is defined as BMI ≥25 kg/m² and obesity is defined as: BMI ≥30 kg/m². * Imaging for evaluation of donors with BMI ≥25 kg/m² such as abdominal US and FibroScan with CAP. * Donors with BMI ≥25 kg/m² will receive life style modification and medical treatment for improvement of steatosis
Key inclusion criteria (2 listed)
- All donors aged >18 years old
- eligible for Liver Transplant
Key exclusion criteria (2 listed)
- -Subjects aged ≤18 years old.
- Donors refused to do FibroScan with CAP
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
Diagnostic Accuracy of FibroScan Controlled Attenuation Parameter (CAP) for Quantitative Assessment of Macrovesicular Steatosis in Living Liver Donors: A Comparative Study with Liver Biopsy
Time frame: 24 month
This study aims to evaluate the diagnostic accuracy of FibroScan Controlled Attenuation Parameter (CAP) for the quantitative assessment of macrovesicular hepatic steatosis in living related liver donors, using liver biopsy histopathological analysis as the reference standard
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Donor Liver Assessment, run by Assiut University.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira M. Abdelmawgod, Lecturer, Tropical Medicine (+201012760437, amiramohmad60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of FibroScan Controlled Attenuation Parameter (CAP) for Quantitative Assessment of Macrovesicular Steatosis in Living Liver Donors: A Comparative Study with Liver Biopsy (time frame: 24 month). 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 2 Nov 2026.