CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
Reviewing records retrospectively of patients undergoing screening endoscopyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05485714
NCT05485714N/ACompleted

Non-invasive Prediction of Esophageal Varices in Patients With Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis; A Single Centre United Arab Emirates Experience

United Arab Emirates University·observational·Posted Aug 3, 2022·Updated Jan 11, 2024

In Brief

An observational study evaluating Reviewing records retrospectively of patients undergoing screening endoscopy for Esophageal Varices and 2 related conditions. Completed, enrolled 73 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Arab Emirates
CollaboratorsTawam Hospital

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 3, 2022
Enrollment StartOct 5, 2022
Primary CompletionMay 1, 2023
Study CompletionAug 1, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.9 years ago

Interventions

Reviewing records retrospectively of patients undergoing screening endoscopyother

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