An observational study in Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis and Liver Fibrosis, sponsored by University Hospital Muenster. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University Hospital Muenster · Observational
This prospective observational study evaluates whether endohepatology changes treatment indications in adults at high risk of metabolic dysfunction-associated steatotic liver disease. Non-invasive testing is followed, when indicated, by a single-session endohepatology assessment including EUS-guided shear-wave elastography, portal pressure gradient measurement and liver biopsy. The primary outcome is treatment reclassification compared with the prospectively documented non-invasive assessment.
Adults with suspected MASLD undergo clinical assessment, laboratory testing, abdominal ultrasound, FIB-4, vibration-controlled transient elastography, controlled attenuation parameter and spleen stiffness measurement. Participants with abnormal or technically unreliable findings undergo endohepatology. Treatment indications based on histology and EUS-PPG are compared with the blinded non-invasive indication. Follow-up continues through month 24. Translational samples include peripheral blood, saliva, stool, portal and hepatic venous blood, liver tissue, and gastrointestinal mucosal biopsies where applicable and consented.
1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.
This study's planned enrollment of 500 is above the median of 152 across 605 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults referred with suspected MASLD and at least one predefined risk criterion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with low-risk and reliable non-invasive findings undergo non-invasive follow-up.
Diagnostic Test: Non-invasive MASLD and portal hypertension assessment
Participants with abnormal or unreliable non-invasive findings undergo endohepatology within 4 to 8 weeks.
Diagnostic Test: Non-invasive MASLD and portal hypertension assessment · Diagnostic Test: Single-session endohepatology assessment
FIB-4, VCTE with liver stiffness and CAP, spleen stiffness, ultrasound, ANTICIPATE-NASH and NICER.
Upper gastrointestinal endoscopy, EUS-SWE, EUS-PPG, EUS-guided liver biopsy and same-day transcutaneous reference examinations.
Proportion of participants with a change in treatment indication after endohepatology
Any change in the indication for MASH-directed pharmacotherapy and/or non-selective beta-blocker therapy compared with the prospectively documented non-invasive indication.
Time frame: At baseline endohepatology assessment, approximately 4 to 8 weeks after screening
Prevalence of histologically significant fibrosis
NASH-CRN fibrosis stage F2 or higher.
Time frame: At baseline endohepatology assessment
Prevalence of EUS-PPG of 10 mmHg or higher
Clinically significant portal hypertension by EUS-PPG threshold.
Time frame: At baseline endohepatology assessment
Procedure-associated serious adverse events
Serious adverse events related to endoscopy, EUS, pressure measurement or biopsy.
Time frame: Up to 30 days after each endohepatology procedure
Hepatic decompensation
Occurence of hepatic decompensation defined as hepatic encephalopathy and/or ascites and/or variceal bleeding
Time frame: From enrollment through month 24
Hepatocellular carcinoma
Development of hepatocellular carcinoma
Time frame: From enrollment through month 24
Major adverse cardiovascular events
Occurence of MACE-Event (cardiovascular death and/or non-deadly myocardial infarction and/or stroke)
Time frame: From enrollment through month 24
Liver transplantation
Liver transplantation within the study period
Time frame: From enrollment through month 24
Mortality
Death within the study period
Time frame: From enrollment through month 24
Plan to share: Undecided
Started Oct 2026 (actual). Primary completion is estimated for Apr 2028, 17 months after the start.
Of 264 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 73. This study's planned 17 months is below that.
Counting every sponsor, half of 284 studies reached it within 42 months; a quarter within 17 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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