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

NCT05485714 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2024-01-11

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Varices
  • Non-alcoholic Fatty Liver
  • Compensated Cirrhosis

Interventions

OTHER

Reviewing records retrospectively of patients undergoing screening endoscopy

Reviewing records retrospectively of patients undergoing screening endoscopy to assess Baveno VI, expanded Baveno VI, Platelet count/spleen diameter and other non-invasive predictors of esophageal varices or varices needing treatment

Sponsors & Collaborators

  • Tawam Hospital

    collaborator OTHER

  • United Arab Emirates University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2023-05-01
Completion
2023-08-01

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485714 on ClinicalTrials.gov