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

NCT05485714 | Completed

• 1 other identifier: UAEU_TWM_MF2058-2022-856
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Platelet count; Spleen diameter; Baveno VI; non-invasive prediction; liver Stiffness; varices needing treatment; Endoscopy

Outcome Measures

Primary Outcomes (1)

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

  To compare various previous known non-invasive predictors of esophageal varices and compare their ability to predict esophageal varices when compared to gold standard i.e. endoscopy. The predictors include; 1. Platelet count to ultrasonographic spleen diameter ratio ((N/mm3)/mm) of \> 909 suggesting esophageal varices are unlikely 2. Baveno VI criteria i.e. liver stiffness measurement (LSM) less than 20 kPa and a platelet count more than than 150,000/μL suggesting esophageal varices are unlikely 3 New expanded Baveno VI criteria i.e. platelet count \>110 × 109 cells/L and LSM \<25 kPa suggesting esophageal varices are unlikely

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

Secondary Outcomes (1)

• Assessing a new non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis

  6 months

Study Arms (1)

Patient with non-alcoholic fatty liver with advanced liver fibrosis

Patient with non-alcoholic fatty liver with advanced liver fibrosis with F3 or F4 stage on Fibroscan without any evidence of previous decompensation like ascites, jaundice or encephalopathy

Other: Reviewing records retrospectively of patients undergoing screening endoscopy

Interventions

Reviewing records retrospectively of patients undergoing screening endoscopy OTHER

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

Patient with non-alcoholic fatty liver with advanced liver fibrosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with Non-alcoholic fatty liver related advanced liver fibrosis confirmed on Fibroscan (stage F3 or F4) referred to Endoscopy Unit Tawam Hospital, Al Ain Abu Dhabi for screening of esophageal varices fulfilling the above-mentioned criteria will be selected. All consecutive patients over the last five years will be selected

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• United Arab Emirates University: lead
• Tawam Hospital: collaborator

Study Sites (1)

Internal Medicine, College of Medicine and Health Sciences

Al Ain City, Abu Dhabi Emirate, 15551, United Arab Emirates

Location

Related Publications (4)

• Agha A, Anwar E, Bashir K, Savarino V, Giannini EG. External validation of the platelet count/spleen diameter ratio for the diagnosis of esophageal varices in hepatitis C virus-related cirrhosis. Dig Dis Sci. 2009 Mar;54(3):654-60. doi: 10.1007/s10620-008-0367-y. Epub 2008 Jul 2.

  PMID: 18594972 BACKGROUND

• Agha A, Abdulhadi MM, Marenco S, Bella A, Alsaudi D, El-Haddad A, Inferrera S, Savarino V, Giannini EG. Use of the platelet count/spleen diameter ratio for the noninvasive diagnosis of esophageal varices in patients with schistosomiasis. Saudi J Gastroenterol. 2011 Sep-Oct;17(5):307-11. doi: 10.4103/1319-3767.84483.

  PMID: 21912056 BACKGROUND

• Giannini E, Botta F, Borro P, Risso D, Romagnoli P, Fasoli A, Mele MR, Testa E, Mansi C, Savarino V, Testa R. Platelet count/spleen diameter ratio: proposal and validation of a non-invasive parameter to predict the presence of oesophageal varices in patients with liver cirrhosis. Gut. 2003 Aug;52(8):1200-5. doi: 10.1136/gut.52.8.1200.

  PMID: 12865282 BACKGROUND

• Pizzamiglio M, Weicker A, de Terwangne C, Henrion J, Descamps OS, De Vos M. Validation of Baveno VI and Expanded-Baveno VI Criteria for predicting gastroesophageal varices in patients with alcoholic and non-alcoholic fatty liver disease. Acta Gastroenterol Belg. 2022 Apr-Jun;85(2):321-329. doi: 10.51821/88.2.9553.

  PMID: 35709776 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Fatty Liver

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: October 5, 2022
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

AE (1)