Baveno VIII Criteria for Portal Hypertension in Egyptian Patients

NCT07842666 — Not yet recruiting, 125 participants, Assiut University

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Cost-Effectiveness and Validation of Baveno VIII Criteria for Detecting Clinically Significant Portal Hypertension in Egyptian Patients With Compensated Advanced Chronic Liver Disease

Registry	NCT07842666
Status	Not yet recruiting
Study type	Observational
Enrollment	125 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Compensated Liver Disease, Esophageal Varices, Portal Hypertension, Chronic Liver Disease
Dates	start 2026-09-26 (estimated), primary completion 2027-09-26 (estimated), completion 2028-03-20 (estimated), first posted 2026-09-25, last updated 2026-09-25

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Prevalence of esophageal varices [Baseline]: Proportion of patients with esophageal varices detected by upper gastrointestinal endoscopy among those with liver stiffness measurement 15-25 kPa.

Secondary outcomes

Prevalence of varices needing treatment [Baseline]: Proportion of patients with varices needing treatment (VNT) on upper gastrointestinal endoscopy.
Mean liver stiffness measurement [Baseline]: Mean liver stiffness value in kPa measured by vibration-controlled transient elastography.
Mean platelet count [Baseline]: Mean platelet count (×10⁹/L).
Diagnostic performance of ANTICIPATE model [Baseline]: Sensitivity, specificity, and area under the ROC curve of the ANTICIPATE model for detecting esophageal varices.
Proportion of patients meeting Baveno VIII rule-out criteria [Baseline]: Proportion of patients with liver stiffness ≤15 kPa and platelet count ≥150×10⁹/L.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* \- 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

Exclusion Criteria:

* \- 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

+Investigators

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