Metabolic Dysfunction-Associated Steatotic Liver DiseaseENDO-MASHNCT07877272
Endohepatology-Based Reclassification of Treatment Indication in High-Risk MASLD
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, run by University Hospital Muenster at 1 site in Germany.
Trial summary
This prospective observational study evaluates whether endohepatology changes treatment indications in adults at high risk of metabolic dysfunction-associated steatotic liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Liver Fibrosis
- What is being tested?
- Non-invasive MASLD and portal hypertension assessment and Single-session endohepatology assessment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 5 Oct 2026to 1 Apr 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults referred with suspected MASLD and at least one predefined risk criterion.
Who may be able to join
- Age 18 years or older
- Written informed consent
- Suspected MASLD
- At least one predefined risk criterion
Who cannot join
- No evidence of MASLD
- HIV infection
- Previous organ transplantation or TIPS
- Current resmetirom therapy
- Decompensated cirrhosis
- Vascular liver disease
Show all 9Show fewer
- Contraindication to endoscopy, sedation, or liver biopsy
- Pregnancy or breastfeeding
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Muenster
Münster
Michael Prof. Praktiknjo, 0049 251 83 44826, michael.praktiknjo@ukmuenster.de
Dominik Dr. van de Loo, MD, 0049 251 83 44476, dominikjulian.vandeloo@ukmuenster.de
About this study
Official title: Endohepatology-Based Reclassification of Treatment Indication in High-Risk Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective, Multicenter Observational Study
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.
Read the detailed description
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.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Liver Fibrosis, Portal Hypertension
- Being tested
- Non-invasive MASLD and portal hypertension assessment, Single-session endohepatology assessment
- Keywords
- MASLD, MASH, Endohepatology, EUS-PPG, EUS-guided liver biopsy, Treatment reclassification
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive MASLD and portal hypertension assessmentDiagnostic test
FIB-4, VCTE with liver stiffness and CAP, spleen stiffness, ultrasound, ANTICIPATE-NASH and NICER.
Single-session endohepatology assessmentDiagnostic test
Upper gastrointestinal endoscopy, EUS-SWE, EUS-PPG, EUS-guided liver biopsy and same-day transcutaneous reference examinations.
| Study group | Role | What they receive |
|---|---|---|
| Low-risk group | Participants with low-risk and reliable non-invasive findings undergo non-invasive follow-up. Receives: Diagnostic Test: Non-invasive MASLD and portal hypertension assessment | |
| Endohepatology group | Participants with abnormal or unreliable non-invasive findings undergo endohepatology within 4 to 8 weeks. Receives: Diagnostic Test: Non-invasive MASLD and portal hypertension assessment; Diagnostic Test: Single-session endohepatology assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline endohepatology assessment, approximately 4 to 8 weeks after screening
Secondary outcomes (8)
Prevalence of histologically significant fibrosis
NASH-CRN fibrosis stage F2 or higher.
Measured: At baseline endohepatology assessment
Prevalence of EUS-PPG of 10 mmHg or higher
Clinically significant portal hypertension by EUS-PPG threshold.
Measured: At baseline endohepatology assessment
Procedure-associated serious adverse events
Serious adverse events related to endoscopy, EUS, pressure measurement or biopsy.
Measured: 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
Measured: From enrollment through month 24
Hepatocellular carcinoma
Development of hepatocellular carcinoma
Measured: From enrollment through month 24
Major adverse cardiovascular events
Occurence of MACE-Event (cardiovascular death and/or non-deadly myocardial infarction and/or stroke)
Measured: From enrollment through month 24
Liver transplantation
Liver transplantation within the study period
Measured: From enrollment through month 24
Mortality
Death within the study period
Measured: From enrollment through month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start5 Oct 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Michael Praktiknjo, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877272
- Sponsor's protocol ID
- ENDO-MASH
- Acronym
- ENDO-MASH
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nass KJ, Zwager LW, van der Vlugt M, Dekker E, Bossuyt PMM, Ravindran S, Thomas-Gibson S, Fockens P. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8.
PubMed 34890695Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.
PubMed 15915461Castera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, Darriet M, Couzigou P, De Ledinghen V. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology. 2005 Feb;128(2):343-50. doi: 10.1053/j.gastro.2004.11.018.
PubMed 15685546Ali AH, Nallapeta NS, Yousaf MN, Petroski GF, Sharma N, Rao DS, Yin F, Davis RM, Bhat A, Swi AIA, Al-Juboori A, Ibdah JA, Hammoud GM. EUS-guided versus percutaneous liver biopsy: A prospective randomized clinical trial. Endosc Ultrasound. 2023 May-Jun;12(3):334-341. doi: 10.1097/eus.0000000000000010. Epub 2023 Jul 25.
PubMed 37693114Wang TJ, Jirapinyo P, Shah R, Schuster K, Papke DJ, Thompson CC, Doyon L, Lautz DB, Ryou M. EUS-guided shear wave elastography for fibrosis screening in patients with obesity and metabolic dysfunction-associated steatotic liver disease: a pilot study (with video). Gastrointest Endosc. 2025 Feb;101(2):456-462.e1. doi: 10.1016/j.gie.2024.10.054. Epub 2024 Oct 29.
PubMed 39481576Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29.
PubMed 36049537Wang TJ, Chang K, Rubin RA, Salgia R, Shami V, Watson A, Khara HS, Yeaton P, Adler DG, Bazarbashi AN, Benmassaoud A, Chen YI, Diehl DL, Draganov P, Duarte-Rojo A, Eves M, Fortune BE, Frandah WW, Gines A, Gjeorgjievski M, Henry ZH, James M, Jirapinyo P, Joshi T, Kankotia R, Khurana S, Kumar S, Kwo PY, Laleman W, Larghi AL, Mahon BS, McHenry SA, Mehta MJ, Mony S, Nilsson JE, Park WG, Sack J, Samarasena J, Santopaolo F, Teoh AY, Van Der Merwe S, Zucker SD, Ryou M. International Expert Delphi Consensus on Endoscopic Ultrasound-guided Portosystemic Pressure Gradient: Best Practices and Future Directions. Clin Gastroenterol Hepatol. 2025 Dec 16:S1542-3565(25)01033-X. doi: 10.1016/j.cgh.2025.12.007. Online ahead of print.
PubMed 41412540Vanderschueren E, Laleman W, Bonne L, Maleux G, Wagner DR, Yeh C, Calvo A, Sendino O, Gines A, Baiges A, Bruno MJ, Garcia-Pagan JC, van der Merwe S. Endoscopic ultrasound-guided portosystemic pressure gradient measurement vs. transjugular balloon occlusion measurement in patients with cirrhosis (ENCOUNTER): A bicentric EU study. JHEP Rep. 2025 May 29;7(8):101466. doi: 10.1016/j.jhepr.2025.101466. eCollection 2025 Aug.
PubMed 40689144Hofer BS, Shalaby S, Kwanten W, Saltini D, Tellez L, Calleja JL, Caceres F, Puente A, Jimenez-Masip A, Moga L, Gutmann D, Pennisi G, Fischer P, Pais R, Bettinger D, Sandmann L, Ardevol A, Sebesta C, Graupera I, Schoenmakers L, Vanwolleghem T, Maderuelo E, Brujats A, Anton A, Pericas JM, Masnou H, Maasoumy B, Ratziu V, Procopet B, Petta S, Tsochatzis EA, Rautou PE, Genesca J, Fortea JI, Alvarado-Tapias E, Llop E, Albillos A, Schepis F, Trauner M, Mandorfer M, Reiberger T, Francque S, Hernandez-Gea V, Semmler G; A Study by the Baveno Cooperation: A European Association for the Study of the Liver Consortium. Hepatic Venous Pressure Gradient, Noninvasive Tests, and Prognosis Across the Subtypes of Advanced Steatotic Liver Disease. Clin Gastroenterol Hepatol. 2026 Jun 11:S1542-3565(26)00438-6. doi: 10.1016/j.cgh.2026.05.033. Online ahead of print.
PubMed 42276315Bassegoda O, Olivas P, Turco L, Mandorfer M, Serra-Burriel M, Tellez L, Kwanten W, Laroyenne A, Farcau O, Alvarado E, Moga L, Vuille-Lessard E, Fortea JI, Ibanez L, Tosetti G, Vanwolleghem T, Larrue H, Burgos-Santamaria D, Stefanescu H, Paternostro R, Cippitelli A, Lens S, Augustin S, Llop E, Laleman W, Trebicka J, Chang J, Masnou H, Zipprich A, Miceli F, Semmler G, Forns X, Primignani M, Banares R, Puente A, Berzigotti A, Rautou PE, Villanueva C, Gines P, Garcia-Pagan JC, Procopet B, Bureau C, Albillos A, Francque S, Reiberger T, Schepis F, Graupera I, Hernandez-Gea V. Decompensation in Advanced Nonalcoholic Fatty Liver Disease May Occur at Lower Hepatic Venous Pressure Gradient Levels Than in Patients With Viral Disease. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2276-2286.e6. doi: 10.1016/j.cgh.2021.10.023. Epub 2021 Oct 21.
PubMed 34688952Ferrusquia-Acosta J, Bassegoda O, Turco L, Reverter E, Pellone M, Bianchini M, Perez-Campuzano V, Ripoll E, Garcia-Criado A, Graupera I, Garcia-Pagan JC, Schepis F, Senzolo M, Hernandez-Gea V. Agreement between wedged hepatic venous pressure and portal pressure in non-alcoholic steatohepatitis-related cirrhosis. J Hepatol. 2021 Apr;74(4):811-818. doi: 10.1016/j.jhep.2020.10.003. Epub 2020 Oct 14.
PubMed 33068638Banares J, Pons M, Reiberger T, Mandorfer M, Jachs M, Semmler G, Colecchia A, Colecchia L, Dajti E, Bureau C, Larrue H, Grgurevic I, Kujundzic PD, Fortea JI, Puente A, Berzigotti A, Tsochatzis E, Bosch J, Abraldes JG, Genesca J; a study by the Baveno Cooperation: an EASL consortium. Refining the Baveno VII criteria for clinically significant portal hypertension: An individual patient data meta-analysis. J Hepatol. 2026 Mar;84(3):543-553. doi: 10.1016/j.jhep.2025.10.014. Epub 2025 Oct 24.
PubMed 41138818Jachs M, Odriozola A, Turon F, Moga L, Tellez L, Fischer P, Saltini D, Kwanten WJ, Grasso M, Llop E, Mendoza YP, Armandi A, Thalhammer J, Pardo C, Colecchia A, Ravaioli F, Maasoumy B, Laleman W, Presa J, Schattenberg JM, Berzigotti A, Calleja JL, Calvaruso V, Francque S, Schepis F, Procopet B, Albillos A, Rautou PE, Garcia-Pagan JC, Puente A, Fortea JI, Reiberger T, Mandorfer M; SSM-100Hz/ACLD Study Group; Baveno Cooperation. Spleen stiffness measurement by vibration-controlled transient elastography at 100 Hz for non-invasive predicted diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a modelling study. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1111-1120. doi: 10.1016/S2468-1253(24)00234-6. Epub 2024 Sep 23.
PubMed 39326431Pons M, Augustin S, Scheiner B, Guillaume M, Rosselli M, Rodrigues SG, Stefanescu H, Ma MM, Mandorfer M, Mergeay-Fabre M, Procopet B, Schwabl P, Ferlitsch A, Semmler G, Berzigotti A, Tsochatzis E, Bureau C, Reiberger T, Bosch J, Abraldes JG, Genesca J. Noninvasive Diagnosis of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease. Am J Gastroenterol. 2021 Apr;116(4):723-732. doi: 10.14309/ajg.0000000000000994.
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