Esophageal Varices Clinical Trial
Official title:
Non-invasive Prediction of Esophageal Varices in Patients With Non-Alcoholic Fatty Liver Disease With Advanced Fibrosis; A Single Centre United Arab Emirates Experience
Verified date | January 2024 |
Source | United Arab Emirates University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | August 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | Internal Medicine, College of Medicine and Health Sciences | Al Ain | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
United Arab Emirates University | Tawam Hospital |
United Arab Emirates,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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; Platelet count to ultrasonographic spleen diameter ratio ((N/mm3)/mm) of > 909 suggesting esophageal varices are unlikely 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 | Assessing a new non-invasive parameters with gold standard Endoscopy in prediction of esophageal varices in patients with fatty liver with advanced fibrosis | To look at various previous suggested predictors and see if there is cut off that exists for a new predictor that involves that all three know risk factors for esophageal varices i.e. Platelet count, spleen diameter on ultrasound and liver stiffness in kPa on fibroscan in the form of novel platelet count/(spleen diameter and Liver stiffness measurement) [(N/cm3)/(cm +kpa)] and compare with with gold standard Upper GI Endoscopy to see if this tool can predict the absence of varices needing treatment in patient with fatty liver and advanced hepatic fibrosis (fibrosis stage F3 or F4) in a tertiary care hospital in Al Ain, Abu Dhabi, United Arab Emirates. | 6 months |
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