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NCT Number: NCT05044663

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

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.

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Key information

Conditions

Chronic Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MASLD will be diagnosed by liver biopsy or ultrasound steatosis / Fibroscan CAP > 250 dB + any 1 criteria of metabolic syndrome:
  • 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,
  • Transjugular intrahepatic portosystemic shunt, significant alcohol intake (> 30 gm/day (M) and 20gm/day (F),
  • Acute on chronic liver failure,
  • AST and/or ALT > 5 times the upper limit of normal.
  • Hepatocellular carcinoma or any space-occupying lesion in the liver,
  • Portal vein thrombosis,
  • Biliary obstruction,
  • HVOTO,
  • Cardiac failure,
  • Prior variceal endotherapy or ongoing beta blocker treatment.
  • HIV,
  • Any malignancy,
  • Pregnancy,
  • ICD / pacemaker,
  • No consent.

Treatment and study plan

No intervention

Other

This is an observational study

Primary outcomes

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

    Time frame: Day 0

Secondary outcomes

  1. Utility of other NITs in predicting VNT in MASLD related cACLD

    Time frame: Day 0

  2. Correlation of LSM and SSM with grade of EV

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease - A Cross-Sectional Study.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2021
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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