Liver Cell DamageNCT06089785
Elastography in Liver Cell Failure
An observational study of Liver Cell Damage, run by Omnia Saad Desoky Mohamed at 1 site in Egypt.
Trial summary
1. evaluation of degree of spleen stiffness in liver cell failure patient by elastography. 2. correlation of degree of spleen stiffness and patient outcome Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cell Damage
- What is being tested?
- elastography
- Type of treatment
- Medical device
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2023to Dec 2027
- How long will I take part?
- 3 Years
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: any patient has any clinical picture for liver cell failure
Who may be able to join
- 1- Age above 18 years. 2-patients with liver cell failure (hepatic encephalopathy, hematemesis, ascites, hepatocellular carcinoma) 3- patient height , Weight
Who cannot join
- 1- patients who refuse to contribute in this study. 2- Age below 18 years. 3-pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Splenic Stiffness in Liver Cell Failure Patients:Role of Elastography
- evaluation of degree of spleen stiffness in liver cell failure patient by elastography.
- correlation of degree of spleen stiffness and patient outcome
Read the detailed description
Portal hypertension (PH) is a major complication of liver cirrhosis, as it predisposes to the development of serious clinical manifestations such as ascites, hepatic encephalopathy and variceal bleeding, aggravating the prognosis of patients.
Liver biopsy and hepatic venous pressure gradient (HVPG) measurements are the current gold standard procedures for determining fibrosis severity and diagnosing PH, respectively; however, both are invasive, limiting their use in clinical practice and larger trials of novel agents. Alternatively, many non-invasive methods have been proposed in order to substitute HVPG. Alterations in the biomechanical properties of the liver or spleen in patients with cirrhosis can be quantified by tissue elastography, which examines the elastic behavior of tissue after a force has been applied Among them, liver stiffness measurement (LSM) has been widely used, as it has been shown to correlate well with HVPG, though this relationship seems to weaken in values of HVPG higher than 12 mmHg, the threshold of serious complications development. Several studies supported the use of spleen stiffness measurement (SSM) instead of LSM, anticipating to a more adequate assessment of this advanced stage of PH. SS measured by ultrasound-based elastography showed good correlation with HVPG, detecting PH with a sensitivity and specificity of 0.88 and 0.92, respectively, and severe PH with a sensitivity and specificity of 0.92 and 0.79, respectively.The aim of this paper is to critically appraise and summarize the literature about the role of SSM as a predictive tool of liver decompensation and prognosis.
- Conditions
- Liver Cell Damage
- Being tested
- elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastographyDevice
evaluation of degree of spleen stiffness in liver cell failure patient by elastography.
| Study group | Role | What they receive |
|---|---|---|
| patients with liver cell failure | patients with liver cell failure and any complications Receives: Device: elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of splenic stiffness in liver cell failure patients: role of elastography
- evaluation of degree of spleen stiffness in liver cell failure patient by elastography.
- correlation of degree of spleen stiffness and patient outcome
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Cell DamageStudies 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
- Cross-sectional
- Enrolment
- 77 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Omnia Saad Desoky Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omnia Saad Desoky Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089785
- Sponsor's protocol ID
- elastography in liver failure
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reiberger T. The Value of Liver and Spleen Stiffness for Evaluation of Portal Hypertension in Compensated Cirrhosis. Hepatol Commun. 2022 May;6(5):950-964. doi: 10.1002/hep4.1855. Epub 2021 Dec 14.
PubMed 34904404Yiyi M, Xiaoqin Q, Lei Z. Spleen Stiffness on Magnetic Resonance Elastography for the Detection of Portal Hypertension: A Systematic Review and Meta-Analysis. Iran J Public Health. 2022 Sep;51(9):1925-1935. doi: 10.18502/ijph.v51i9.10548.
PubMed 36743372
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Splenic Stiffness in Liver Cell Failure Patients:Role of Elastography
- ClinicalTrials.gov ID
- NCT06089785
- Acronym / sponsor ID
- elastography in liver failure
- Conditions
- Liver Cell Damage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Omnia Saad Desoky MohamedUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Oct 2023 (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.
- evaluation of degree of spleen stiffness in liver cell failure patient by elastography.
- correlation of degree of spleen stiffness and patient outcome
Detailed description
Portal hypertension (PH) is a major complication of liver cirrhosis, as it predisposes to the development of serious clinical manifestations such as ascites, hepatic encephalopathy and variceal bleeding, aggravating the prognosis of patients.
Liver biopsy and hepatic venous pressure gradient (HVPG) measurements are the current gold standard procedures for determining fibrosis severity and diagnosing PH, respectively; however, both are invasive, limiting their use in clinical practice and larger trials of novel agents. Alternatively, many non-invasive methods have been proposed in order to substitute HVPG. Alterations in the biomechanical properties of the liver or spleen in patients with cirrhosis can be quantified by tissue elastography, which examines the elastic behavior of tissue after a force has been applied Among them, liver stiffness measurement (LSM) has been widely used, as it has been shown to correlate well with HVPG, though this relationship seems to weaken in values of HVPG higher than 12 mmHg, the threshold of serious complications development. Several studies supported the use of spleen stiffness measurement (SSM) instead of LSM, anticipating to a more adequate assessment of this advanced stage of PH. SS measured by ultrasound-based elastography showed good correlation with HVPG, detecting PH with a sensitivity and specificity of 0.88 and 0.92, respectively, and severe PH with a sensitivity and specificity of 0.92 and 0.79, respectively.The aim of this paper is to critically appraise and summarize the literature about the role of SSM as a predictive tool of liver decompensation and prognosis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with liver cell failure | – | Device: elastographypatients with liver cell failure and any complications |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- any patient has any clinical picture for liver cell failure
Key inclusion criteria (1 listed)
- 1- Age above 18 years. 2-patients with liver cell failure (hepatic encephalopathy, hematemesis, ascites, hepatocellular carcinoma) 3- patient height , Weight
Key exclusion criteria (1 listed)
- 1- patients who refuse to contribute in this study. 2- Age below 18 years. 3-pregnancy and breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastographyevaluation of degree of spleen stiffness in liver cell failure patient by elastography. | Device | patients with liver cell failure |
Primary outcome
Evaluation of splenic stiffness in liver cell failure patients: role of elastography
Time frame: 4 years
1. evaluation of degree of spleen stiffness in liver cell failure patient by elastography. 2. correlation of degree of spleen stiffness and patient outcome
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 18 Oct 2023.
- Results publication: PubMed 34904404Reiberger T. The Value of Liver and Spleen Stiffness for Evaluation of Portal Hypertension in Compensated Cirrhosis. Hepatol Commun. 2022 May;6(5):950-964. doi: 10.1002/hep4.1855. Epub 2021 Dec 14.
- Results publication: PubMed 36743372Yiyi M, Xiaoqin Q, Lei Z. Spleen Stiffness on Magnetic Resonance Elastography for the Detection of Portal Hypertension: A Systematic Review and Meta-Analysis. Iran J Public Health. 2022 Sep;51(9):1925-1935. doi: 10.18502/ijph.v51i9.10548.
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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.
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 Liver Cell Damage, run by Omnia Saad Desoky Mohamed at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 18 Oct 2023. 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 Egypt. 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?
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 omnia saad (010049763, saadomnia19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of splenic stiffness in liver cell failure patients: role of elastography (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06089785, which also lists 2 linked publications.
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 18 Oct 2023.