Endohepatology-based reclassification of treatment indication in high-risk MASLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study examines if endohepatology findings can modify treatment indications in adults with suspected MASLD. Participants undergo a non-invasive assessment first, and those with unreliable results receive a single-session endohepatology evaluation that may include EUS-guided elastography, portal pressure measurement, and liver biopsy. The primary outcome is whether treatment indications change after the endohepatology assessment compared with the initial non-invasive assessment. Follow-up continues up to 24 months, with translational samples collected when consented. The study explores how invasive liver evaluation can complement non-invasive tests to guide therapy decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Written informed consent
* Suspected MASLD
* At least one predefined risk criterion

Exclusion Criteria:

* No evidence of MASLD
* HIV infection
* Previous organ transplantation or TIPS
* Current resmetirom therapy
* Decompensated cirrhosis
* Vascular liver disease
* Contraindication to endoscopy, sedation, or liver biopsy
* Pregnancy or breastfeeding
* Inability to provide informed consent

Where it's running

• University Hospital Muenster
  Münster, Germany Recruiting

Study contacts

• Study coordinator: Michael Prof. Dr. Praktiknjo, MD PhD
• Email: michael.praktiknjo@ukmuenster.de
• Phone: 0049 251 83 44826

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.