Compensated Liver DiseaseNCT07842666
Baveno VIII Criteria for Portal Hypertension in Egyptian Patients
An observational study of Compensated Liver Disease and Esophageal Varices, run by Assiut University.
Trial summary
This prospective observational study aims to validate Baveno VIII criteria for detection of clinically significant portal hypertension and to evaluate additional predictors of esophageal varices in Egyptian patients with compensated advanced chronic liver disease and liver stiffness measurement between 15 and 25 kPa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compensated Liver Disease, Esophageal Varices, Portal Hypertension
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 20 Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with compensated advanced chronic liver disease attending Al-Rajhi Liver Hospital, Assiut University.
Who may be able to join
- - Age 18 years or older
- Compensated advanced chronic liver disease (cACLD)
- Liver stiffness measurement by VCTE under fasting conditions
- Liver stiffness measurement between 15 and 25 kPa
- Eligible for upper gastrointestinal endoscopy
- Written informed consent
Who cannot join
- - Previous variceal bleeding or band ligation
- TIPS, hepatocellular carcinoma, or portal vein thrombosis
- Acute liver failure
- Overt hepatic encephalopathy
- Severe ascites affecting LSM reliability
- Concurrent viral hepatitis and MASLD
- Pregnancy or refusal to undergo endoscopy
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: Cost-Effectiveness and Validation of Baveno VIII Criteria for Detecting Clinically Significant Portal Hypertension in Egyptian Patients With Compensated Advanced Chronic Liver Disease
This prospective observational study aims to validate Baveno VIII criteria for detection of clinically significant portal hypertension and to evaluate additional predictors of esophageal varices in Egyptian patients with compensated advanced chronic liver disease and liver stiffness measurement between 15 and 25 kPa.
Read the detailed description
Non-invasive criteria based on liver stiffness measurement and platelet count are recommended for identifying clinically significant portal hypertension. Patients with liver stiffness between 15 and 25 kPa represent an indeterminate group.
This observational study will include adult patients with compensated advanced chronic liver disease and liver stiffness measurement of 15-25 kPa. All eligible participants will undergo upper gastrointestinal endoscopy to detect esophageal varices. The performance of Baveno VIII criteria and additional clinical predictors will be evaluated.
- Keywords
- FibroScan, Baveno VIII, Assiut, Liver stiffness, Clinically significant portal hypertension
- Medical subject headings
- Esophageal and Gastric Varices, Hypertension, Portal
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 |
|---|---|---|
| Single cohort: Patients with cACLD and LSM 15-25 kPa | Adult patients with compensated advanced chronic liver disease and liver stiffness measurement between 15 and 25 kPa who will undergo upper gastrointestinal endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of esophageal varices
Proportion of patients with esophageal varices detected by upper gastrointestinal endoscopy among those with liver stiffness measurement 15-25 kPa.
Measured: Baseline
Secondary outcomes (5)
Prevalence of varices needing treatment
Proportion of patients with varices needing treatment (VNT) on upper gastrointestinal endoscopy.
Measured: Baseline
Mean liver stiffness measurement
Mean liver stiffness value in kPa measured by vibration-controlled transient elastography.
Measured: Baseline
Mean platelet count
Mean platelet count (×10⁹/L).
Measured: Baseline
Diagnostic performance of ANTICIPATE model
Sensitivity, specificity, and area under the ROC curve of the ANTICIPATE model for detecting esophageal varices.
Measured: Baseline
Proportion of patients meeting Baveno VIII rule-out criteria
Proportion of patients with liver stiffness ≤15 kPa and platelet count ≥150×10⁹/L.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compensated Liver DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marven Joseph Louis Agrabas, Assiut University
- Investigators
- Hanan m nafeh, prof, Study chair, Tropical Medicine & Gastroenterology Department, Assiut University HospitalsMohamed A Medhat, Prof, Study chair, Tropical Medicine & Gastroenterology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842666
- Sponsor's protocol ID
- BavenoVIII-CSPH-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness and Validation of Baveno VIII Criteria for Detecting Clinically Significant Portal Hypertension in Egyptian Patients With Compensated Advanced Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT07842666
- Acronym / sponsor ID
- BavenoVIII-CSPH-Assiut-2026
- Keywords
- FibroScan, Baveno VIII, Assiut, Liver stiffness, Clinically significant portal hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 25 Sep 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.
This prospective observational study aims to validate Baveno VIII criteria for detection of clinically significant portal hypertension and to evaluate additional predictors of esophageal varices in Egyptian patients with compensated advanced chronic liver disease and liver stiffness measurement between 15 and 25 kPa.
Detailed description
Non-invasive criteria based on liver stiffness measurement and platelet count are recommended for identifying clinically significant portal hypertension. Patients with liver stiffness between 15 and 25 kPa represent an indeterminate group.
This observational study will include adult patients with compensated advanced chronic liver disease and liver stiffness measurement of 15-25 kPa. All eligible participants will undergo upper gastrointestinal endoscopy to detect esophageal varices. The performance of Baveno VIII criteria and additional clinical predictors will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Patients with cACLD and LSM 15-25 kPa | – | –Adult patients with compensated advanced chronic liver disease and liver stiffness measurement between 15 and 25 kPa who will undergo upper gastrointestinal endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with compensated advanced chronic liver disease attending Al-Rajhi Liver Hospital, Assiut University.
Key inclusion criteria (6 listed)
- - Age 18 years or older
- Compensated advanced chronic liver disease (cACLD)
- Liver stiffness measurement by VCTE under fasting conditions
- Liver stiffness measurement between 15 and 25 kPa
- Eligible for upper gastrointestinal endoscopy
Key exclusion criteria (7 listed)
- - Previous variceal bleeding or band ligation
- TIPS, hepatocellular carcinoma, or portal vein thrombosis
- Acute liver failure
- Overt hepatic encephalopathy
- Severe ascites affecting LSM reliability
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
Prevalence of esophageal varices
Time frame: Baseline
Proportion of patients with esophageal varices detected by upper gastrointestinal endoscopy among those with liver stiffness measurement 15-25 kPa.
5 secondary outcomes
Prevalence of varices needing treatment
Time frame: Baseline
Mean liver stiffness measurement
Time frame: Baseline
Mean platelet count
Time frame: Baseline
Diagnostic performance of ANTICIPATE model
Time frame: Baseline
Proportion of patients meeting Baveno VIII rule-out criteria
Time frame: Baseline
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 25 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Hanan m nafeh, prof study chair
Tropical Medicine & Gastroenterology Department, Assiut University Hospitals
Mohamed A Medhat, Prof study chair
Tropical Medicine & Gastroenterology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Compensated Liver Disease and Esophageal Varices, 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 6 inclusion and 7 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 25 Sep 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 Marven J Louis, Resident (01551357988, marvin.18313586@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of esophageal varices (time frame: Baseline). 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 25 Sep 2026.