CompletedNot Applicable

Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease.

India325 participantsStarted 2021-09-18

Plain-language summary

Patients with chronic liver disease (CLD) are at risk of developing clinically significant portal hypertension (CSPH). In the Baveno VI consensus a new term "compensated advanced chronic liver disease (cACLD)'' has been proposed to better reflect that the spectrum of severe fibrosis and cirrhosis is a continuum in asymptomatic patients. Liver stiffness by TE is sufficient to suspect cACLD in asymptomatic subjects with known causes of CLD. TE values \<10 kPa in the absence of other known clinical signs rule out cACLD; values between 10 and 15 kPa are suggestive of cACLD but need further test for confirmation; values \>15 kPa are highly suggestive of cACLD. Patients with a liver stiffness \<20 kPa and with a platelet count \>150,000 have a \< 5 % risk of having varices requiring treatment, and can avoid screening endoscopy. SSM can also predict the presence of CSPH and varices requiring treatment. Because of restrictive nature of Baveno VI, recent Baveno VII guidelines state that patients not satisfying Baveno VI criterai acan have endoscopy avoided if their spleen stiffness is less than 40kPa. Some studies have shown superiority of splenic stiffness over liver stiffness in predicting varices requiring treatment likely attributable to the better performance of SSM compared with LSM in more severe portal hypertension because it reflects better the hemodynamic component of portal hypertension. However, there are few studies on MASLD and most are on viral hepatitis related cACLD. Moreover, very few studies are published on splenic stiffness from Indian subcontinent. Hence, we intend to do the study assessing diagnostic utility of splenic and liver stiffness and validate the Baveno VII algorothm in predicting varices needing treatment in MASLD related cACLD and compare from other noninvasive markers.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Waist circumference 90 ≥ cm for males or ≥80 cm for females
✓. Triglycerides ≥150 mg/dL
✓. HDL-C \< 40 mg/dL in males or \< 50 mg/dl in females
✓. systolic blood pressure (SBP) ≥130 mm Hg or diastolic blood pressure (DBP) ≥ 85 mmHg or both and
✓. Fasting plasma glucose ≥ 100 mg/dL. cACLD is defined with Liver stiffness ≥10 kPa. Ultrasound examination, blood examination and upper gastrointestinal endoscopy will be performed within 1 month of Fibroscan examination. HVPG if indicated will be done within 1 month of Fibroscan.

Exclusion criteria

✕. Age \< 18 and \> 70 years, Other etiologies of liver disease.
✕. Past or present history of decompensation (ascites, variceal bleed, hepatic encephalopathy, jaundice),
✕. Child Pugh B or C,
✕. unreliable liver and splenic stiffness in Fibroscan examination,

What they're measuring

Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD.

Timeframe: Day 0

Trial details

NCT IDNCT05044663

SponsorInstitute of Liver and Biliary Sciences, India

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-28

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