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Baveno VIII Criteria for Portal Hypertension in Egyptian Patients

ConditionsCompensated Liver DiseaseEsophageal VaricesPortal HypertensionChronic Liver Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

- Previous variceal bleeding or band ligation

TIPS, hepatocellular carcinoma, or portal vein thrombosis

Acute liver failure

Overt hepatic encephalopathy

Trial population

Adult patients with compensated advanced chronic liver disease attending Al-Rajhi Liver Hospital, Assiut University.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

125 Participants
are grouped into 1 trial group
Group A: Single cohort: Patients with cACLD and LSM 15-25 kPa

Trial outcomes

Primary outcomes

1

Prevalence of esophageal varices

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

Time frame
Baseline

Secondary outcomes

1

Prevalence of varices needing treatment

Proportion of patients with varices needing treatment (VNT) on upper gastrointestinal endoscopy.

Time frame
Baseline
2

Mean liver stiffness measurement

Mean liver stiffness value in kPa measured by vibration-controlled transient elastography.

Time frame
Baseline
3

Mean platelet count

Mean platelet count (×10⁹/L).

Time frame
Baseline
4

Diagnostic performance of ANTICIPATE model

Sensitivity, specificity, and area under the ROC curve of the ANTICIPATE model for detecting esophageal varices.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: