Baveno VIII Criteria for Portal Hypertension in Egyptian Patients

NCT07842666 | Not Yet Recruiting

• 1 other identifier: BavenoVIII-CSPH-Assiut-2026
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

FibroScan; Baveno VIII; Assiut; Liver stiffness; Clinically significant portal hypertension

Outcome Measures

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.

  Baseline

Secondary Outcomes (5)

• Prevalence of varices needing treatment

  Baseline

• Mean liver stiffness measurement

  Baseline

• Mean platelet count

  Baseline

• Diagnostic performance of ANTICIPATE model

  Baseline

• Proportion of patients meeting Baveno VIII rule-out criteria

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hypertension, Portal

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases

Study Officials

• Hanan m nafeh, prof

  Tropical Medicine & Gastroenterology Department, Assiut University Hospitals

  STUDY CHAIR

• Mohamed A Medhat, Prof

  Tropical Medicine & Gastroenterology Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Marven J Louis, Resident

CONTACT

01551357988; marvin.18313586@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Tropical Medicine & Gastroenterology

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: September 26, 2026
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): March 20, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share