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Not yet recruitingNCT07842666Updated Sep 25, 2026

Baveno VIII Criteria for Portal Hypertension in Egyptian Patients

An observational study in Compensated Liver Disease, Esophageal Varices and Portal Hypertension, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Compensated Liver Disease
  • Esophageal Varices
  • Portal Hypertension
  • Chronic Liver Disease

Keywords

  • FibroScan
  • Baveno VIII
  • Assiut
  • Liver stiffness
  • Clinically significant portal hypertension
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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

  5. Proportion of patients meeting Baveno VIII rule-out criteria

    Proportion of patients with liver stiffness ≤15 kPa and platelet count ≥150×10⁹/L.

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07842666
Lead sponsor
Assiut University
Responsible party
Marven Joseph Louis Agrabas (Resident Physician, Department of Tropical Medicine & Gastroenterology, Assiut University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 26, 2026 (estimated)
Primary completion
Sep 26, 2027 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Marven J Louis, Resident
Contact
marvin.18313586@med.aun.edu.eg
01551357988
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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