CompletedNot Applicable

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

United Arab Emirates73 participantsStarted 2022-10-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion Criteria: * Patient diagnosed to have non-alcohol fatty liver disease * Evidence of Liver stiffness measurement of \> 9.9 KPa (indicative of \>F3 fibrosis ). * Periportal hepatic fibrosis and liver echotexture changes confirmed by an experienced radiologist with expertise in Ultrasound. * Vitally stable patients (without massive bleeding, encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, shock). * Compensated Liver cirrhosis (no evidence of decompensation previously) Exclusion Criteria: * Active alcohol abuse (abstinence of alcohol for less than six months). * Evidence of other etiology for liver cirrhosis like viral infection (HBsAg +ve or Anti-HCV seropositivity or viral DNA seen in past/present) or immune/ congenital cause of liver cirrhosis (like autoimmune, congenital hepatic fibrosis etc) * Co-morbid liver or biliary disease (hepatoma, biliary channel obstruction). * Evidence of band ligation/sclerotherapy, portosystemic shunting procedure or surgery for portal hypertension in the past

What they're measuring

Comparing non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis

Timeframe: Chart review of selected patients who underwent screening endoscopy over the last 5 years; to be completed in 6 months

Trial details

NCT IDNCT05485714

SponsorUnited Arab Emirates University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-05-01