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New study: a quick scan may predict bleeding risk in fatty liver disease

NCT ID NCT05044663

Knowledge-focused Sponsor: Institute of Liver and Biliary Sciences, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 325 people with fatty liver disease and early-stage liver scarring to see if a non-invasive scan (measuring liver and spleen stiffness) could predict which patients have dangerous veins in the esophagus that might bleed. Currently, patients often need a camera down the throat (endoscopy) to check. The goal was to see if the scan could safely replace that test. The study was completed in India and focused on validating existing guidelines for this specific patient group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

325 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive patients of MASLD related cACLD (Liver Stiffness ≥10 kPa).

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * MASLD will be diagnosed by liver biopsy or ultrasound steatosis / Fibroscan CAP \> 250 dB + any 1 criteria of metabolic syndrome: 1. Waist circumference 90 ≥ cm for males or ≥80 cm for females 2. Triglycerides ≥150 mg/dL 3. HDL-C \< 40 mg/dL in males or \< 50 mg/dl in females 4. systolic blood pressure (SBP) ≥130 mm Hg or diastolic blood pressure (DBP) ≥ 85 mmHg or both and 5. 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: 1. Age \< 18 and \> 70 years, Other etiologies of liver disease. 2. Past or present history of decompensation (ascites, variceal bleed, hepatic encephalopathy, jaundice), 3. Child Pugh B or C, 4. unreliable liver and splenic stiffness in Fibroscan examination, 5. Transjugular intrahepatic portosystemic shunt, significant alcohol intake (\> 30 gm/day (M) and 20gm/day (F), 6. Acute on chronic liver failure, 7. AST and/or ALT \> 5 times the upper limit of normal. 8. Hepatocellular carcinoma or any space-occupying lesion in the liver, 9. Portal vein thrombosis, 10. Biliary obstruction, 11. HVOTO, 12. Cardiac failure, 13. Prior variceal endotherapy or ongoing beta blocker treatment. 14. HIV, 15. Any malignancy, 16. Pregnancy, 17. ICD / pacemaker, 18. No consent.

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Conditions

The condition(s) this trial relates to.

liver disorder metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic liver disease

Contacts and locations

Locations

  • Institute of Liver & Biliary Sciences

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.