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NCT05485714

Non-invasive Prediction of Esophageal Varices in Patients With Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis

Completed Last updated 11 January 2024
What this trial tests

trial testing Reviewing records retrospectively of patients undergoing screening endoscopy in Esophageal Varices in 73 participants. Completed in 1 August 2023.

Timeline
5 October 2022
Primary endpoint
1 May 2023
1 August 2023

Quick facts

Lead sponsorUnited Arab Emirates University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment73
Start date5 October 2022
Primary completion1 May 2023
Estimated completion1 August 2023
Sites1 location across United Arab Emirates

Drugs / interventions tested

Conditions studied

Sponsor

United Arab Emirates University

Who can join

Adults 18 to 80, any sex, with Esophageal Varices or Non-alcoholic Fatty Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-alcoholic fatty liver disease (NAFLD) is defined as accumulation of fat in the liver which is not related to either alcohol excess or other causes such viral infection, immune-mediated, or medication related which can lead to fibrosis and later-on, cirrhosis. Over the last years NAFLD related liver cirrhosis has become the commonest cause of chronic liver disease worldwide. Portal hypertension is the major complication caused by increased splanchnic blood flow which leads to development of oesophageal varices (OV). Almost all of the patients with portal hypertension can develop OV sometime in their life and one third of those will bleed, hence identifying the presence of OV is a an important aspect of diagnostic workup of these patients with portal hypertension. Upper digestive camera test/endoscopy is the only means to diagnose and grade OV but endoscopy is an invasive procedure and its cost effectiveness for screening is also questionable. These limitations and the ever-increasing workload on endoscopy units has led many researchers to identify some parameters that can non-invasively diagnose OV. Researchers have proposed use of platelet count/spleen diameter ratio, liver stiffness on Fibroscan among many non-invasive tools to predict OV in patients with portal hypertension with success. Recently criteria proposed in Baveno VI conference, (Baveno-IV Criteria) recommended that screening endoscopy can be avoided in patients with compensated advanced chronic liver disease (cACLD) with liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL with an expanded Baveno-IV criteria suggesting platelet count \>110 × 109 cells/L and LSM \<25 kPa can spare even more endoscopies with a risk of missing varices needing treatment (VNT) being minimal.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Exploring new noninvasive parameters to predict oesophageal varices in patients with NAFLD-associated compensated liver cirrhosis.
    Agha A, Pasta A, Calabrese F, Anwar E, et al · · 2025 · PMID 40191516 · DOI 10.5114/pg.2024.139210

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Other recruiting trials for Esophageal Varices

Currently open trials in the same condition.

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Data sources for this page

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