Liver DiseasesDETECTNCT06523608
Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
An observational study of Liver Diseases and Hepatocellular Carcinoma, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The aim of this observational study is to predict the short- and long-term development of acute severe disease events, de novo hepatocarcinoma (HCC) and mortality in patients with advanced chronic liver disease using the M10S20 (Liver stiffness and Model for End-Stage Liver Disease Score [MELD] combined) and PLEASE… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Hepatocellular Carcinoma, Hepatocarcinoma
- What is being tested?
- Standard survillance protocol and Stratified survillance protocol
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2024to Sep 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients should be included in the study if they are hospitalized with suspected chronic liver liver disease of viral and/or steatotic origin.
Who may be able to join
- The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria)
Who cannot join
- Pregnancy
- Age <18
- Evidence of current malignancy except for non-melanocytic skin cancer
- Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (New York Heart Association (NYHA) > II); severe chronic pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) > III), severe neurological and psychiatric disorders).
- Human Immunodeficiency Virus (HIV) positive patients.
- Previous liver or other transplantation.
- Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
- Physician's denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).
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, North Rhine-Westphalia, 48149
Jonel Profesor Dr. Dr. med Trebicka, +49 251 83-59689, jonel.trebicka@ukmuenster.de
Josune Cabello Calleja, +34 688689194, josune.cabello@ukmuenster.de
About this study
Official title: Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms
The aim of this observational study is to predict the short- and long-term development of acute severe disease events, de novo hepatocarcinoma (HCC) and mortality in patients with advanced chronic liver disease using the M10S20 (Liver stiffness and Model for End-Stage Liver Disease Score [MELD] combined) and PLEASE (Platelet, Etiology, Age, Sex und Elastography) scores, as well as the validation of the cost-effectiveness of the algorithm.
Patients in this study are randomly divided into two groups:
- Control group: patients are examined according to the current clinical standard protocol (biannual follow-up).
- Stratified surveillance program:
- High-risk patients will receive an appointment for a hospital visit every 3 months.
- Low-risk patients could receive an appointment in one year. When necessary, if decompensation develops or HCC occurs, patients could be followed-up more frequently.
Read the detailed description
Patients who are hospitalized with advanced chronic liver disease are randomly divided into two groups.
Patients in the control group are examined according to the current clinical standard protocol (biannual follow-up) or more frequently when decompensation or HCC develops.
Patients in the study group will be stratified for the risk of decompensation/mortality and de novo-HCC-risk, based on the M10S20 ([Liver stiffness and MELD combined]) and PLEASE ([Platelet, Etiology, Age, Sex und Elastography]) scores.
High-risk patients will be allocated for a further computer tomography (CT) or magnetic resonance imaging (MRI) examination and an alpha-fetoprotein (AFP) examination to exclude HCC and receive another appointment for a hospital visit within 3 months.
Low-risk patients could receive an appointment in one year. Patients in both arms, either outpatient or inpatient, will undergo at each visit an ultrasound examination with liver stiffness measurement and a routine blood test. Other examinations will be carried out according to standard medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, CT, MRI, endoscopies, bone marrow punctures, elastographies, transjugular intrahepatic portosystemic shunt (TIPS) implantations, operations, etc. will be performed as part of the usual diagnostic clarification.
Hepatic encephalopathy is a decompensation event that will be diagnosed based on the West-Haven criteria, the number-connection test, the flicker frequency analysis and electroencephalogram. Written consent is required for every admitted patient. Data protection concept: When a patient is enrolled in the study, a center-specific study ID is first assigned for the purpose of pseudonymization.
The data collected is documented in an Excel spreadsheet. The assignment of the center-specific study ID to the respective patient is only possible for the respective investigator (Prof. Dr. Trebicka) and his staff (study nurse). For statistical evaluations, an analysis-specific data table will be created, which can be processed with an appropriate statistics program.
Patients cannot be identified with the data collected and the scientific research that derives from it.
- Being tested
- Standard survillance protocol, Stratified survillance protocol
- Medical subject headings
- Liver Diseases, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard survillance protocolOther
Patients will be followed every 6 months. They will undergo at each visit an ultrasound examination including liver stiffness and a routine blood test, including AFP. Other examinations are carried out according to the standard of medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, computer tomography, MR-tomography, endoscopies, bone marrow punctures, elastographies, TIPS implantations, operations, etc. will be performed as part of the usual diagnostic clarification.
Stratified survillance protocolOther
Based on PLEASE and M10LS20 scores, patients will be followed every 3 or 12 months. Low-risk patients will be followed once per year, and high-risk patients every 3 months.
They will undergo at each visit an ultrasound examination including liver stiffness and a routine blood test, including AFP. Other examinations are carried out according to the standard of medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, computer tomography, MR-tomography, endoscopies, bone marrow punctures, elastographies, TIPS implantations, operations, etc. will be performed as part of the usual diagnostic clarification.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients in the control group are examined according to standard protocol (with a biannual follow-up) or more frequently when there is a development of decompensation or HCC. Receives: Other: Standard survillance protocol | |
| Group with stratified surveillance | Patients in the study group will be stratified for the risk of decompensation/mortality and de novo-HCC-risk, based on the M10S20 ([Liver stiffness and MELD combined]) and PLEASE ([Platelet, Etiology, Age, Sex und Elastography]) scores.
High-risk patients are allocated for a further CT/MRI examination and an AFP examination to exclude HCC and receive another appointment for a hospital visit within 3 months.
Low-risk patients receive an appointment in one year. Receives: Other: Stratified survillance protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality rate and liver-related mortality rate
Measured: 2 years
Liver transplantation
Incidence of liver transplantation during follow-up period and time until liver transplantation.
Measured: 2 years
Secondary outcomes (8)
De novo HCC
Prediction of the risk of de novo HCC in patients with advanced chronic liver disease, based on the stratified surveillance, which can lead to earlier detection and treatment.
Measured: 2 years
Acute liver decompensations
The acute occurrence of one or more complications of chronic portal hypertension, such as in patients with liver cirrhosis, a stable condition can develop into an acute decompensation. There is as well a new syndrome in patients with liver cirrhosis, which is characterized by a significantly increased hospitalization and a short-term (28-day) mortality rate. This syndrome is known as acute-on-chronic liver liver failure (ACLF).
Portal hypertension is the driving force behind acute decompensation, while in the course of further decompensation and development of ACLF, an increasing, severe systemic inflammatory reaction is added.
Measured: 2 years
Therapy in patients who develop HCC during follow-up
Assesment in the electronic case report form of number and type of therapies used to treat HCC (liver ablation, liver resection, chemoembolization, radiation or systemic therapy) when the patients develop HCC during the follow-up period.
Measured: 2 years
Analysis of cost-effectiveness of the new algorithm compared to the routine follow-up
This outcome will be measured using the Markov model, which compares effectiveness based on Quality-adjusted life-years (QALYs) to the costs of each algorithm.
Measured: 2 years
Analysis of proteome and metabolome in patients included into the study
Extraction of 40 ml of blood (30ml EDTA blood and 10ml serum) will be taken at each visit to the patient in addition to the regular diagnostics.
This blood samples will be used to measure inflammatory markers (e.g. cytokines), components of the extracellular matrix components (e.g. collagens, matrix metalloproteinases), markers of bacterial translocation (e.g. LPS).
Measured: 2 years
Analysis of intestinal and circulating microbiome in patients included into the study
Extraction of 40 ml of blood (30ml EDTA blood and 10ml serum) will be performed at each visit to the patient in addition to the regular diagnostics.
A measurement of metagenome and 16S rRNA sequencing analyses will be performed in blood as well in stool samples to determine the composition of the intestinal and circulating microbiome.
Measured: 2 years
Influence of circulating immune cells in HCC development and progression
Extraction of 40 ml of blood (30ml EDTA blood and 10ml serum) will be performed at each visit to the patient in addition to the regular diagnostics.
From these blood samples circulating immune cells will be isolated, in order to investigate their influence on the disease.
Measured: 2 years
Influence of transcriptome and metagenome in HCC development and progression
Extraction 30ml EDTA blood for DNA analysis will be performed at each visit to the patient in addition to the regular diagnostics. DNA/RNA extraction is used for transcriptome and metagenome analyses.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Jonel Trebicka, University Hospital Muenster
- Investigators
- Jonel Trebicka, Prof. Dr. med., Principal investigator, Department of Internal Medicine B, University Hospital Muenster, Muenster, GermanyJonel Trebicka, Prof. Dr. med., Principal investigator, European Foundation for Study of Chronic Liver Failure, Barcelona, SpainJonel Trebicka, Prof. Dr. med., Principal investigator, Department of Gastroenterology and Hepatology, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523608
- Sponsor's protocol ID
- 2023-237-f-S
- Acronym
- DETECT
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Franchis R; Baveno V Faculty. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2010 Oct;53(4):762-8. doi: 10.1016/j.jhep.2010.06.004. Epub 2010 Jun 27. No abstract available.
PubMed 20638742Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172.
PubMed 11172350Jansen C, Moller P, Meyer C, Kolbe CC, Bogs C, Pohlmann A, Schierwagen R, Praktiknjo M, Abdullah Z, Lehmann J, Thomas D, Strassburg CP, Latz E, Mueller S, Rossle M, Trebicka J. Increase in liver stiffness after transjugular intrahepatic portosystemic shunt is associated with inflammation and predicts mortality. Hepatology. 2018 Apr;67(4):1472-1484. doi: 10.1002/hep.29612. Epub 2018 Feb 20.
PubMed 29059466Praktiknjo M, Book M, Luetkens J, Pohlmann A, Meyer C, Thomas D, Jansen C, Feist A, Chang J, Grimm J, Lehmann J, Strassburg CP, Abraldes JG, Kukuk G, Trebicka J. Fat-free muscle mass in magnetic resonance imaging predicts acute-on-chronic liver failure and survival in decompensated cirrhosis. Hepatology. 2018 Mar;67(3):1014-1026. doi: 10.1002/hep.29602. Epub 2018 Jan 24.
PubMed 29059469Lehmann J, Praktiknjo M, Nielsen MJ, Schierwagen R, Meyer C, Thomas D, Violi F, Strassburg CP, Bendtsen F, Moller S, Krag A, Karsdal MA, Leeming DJ, Trebicka J. Collagen type IV remodelling gender-specifically predicts mortality in decompensated cirrhosis. Liver Int. 2019 May;39(5):885-893. doi: 10.1111/liv.14070. Epub 2019 Mar 7.
PubMed 30739387Luo X, Leanza J, Massie AB, Garonzik-Wang JM, Haugen CE, Gentry SE, Ottmann SE, Segev DL. MELD as a metric for survival benefit of liver transplantation. Am J Transplant. 2018 May;18(5):1231-1237. doi: 10.1111/ajt.14660. Epub 2018 Feb 19.
PubMed 29316310Jansen C, Bogs C, Verlinden W, Thiele M, Moller P, Gortzen J, Lehmann J, Praktiknjo M, Chang J, Krag A, Strassburg CP, Francque S, Trebicka J. Algorithm to rule out clinically significant portal hypertension combining Shear-wave elastography of liver and spleen: a prospective multicentre study. Gut. 2016 Jun;65(6):1057-8. doi: 10.1136/gutjnl-2016-311536. Epub 2016 Feb 19. No abstract available.
PubMed 26896458Herrmann E, de Ledinghen V, Cassinotto C, Chu WC, Leung VY, Ferraioli G, Filice C, Castera L, Vilgrain V, Ronot M, Dumortier J, Guibal A, Pol S, Trebicka J, Jansen C, Strassburg C, Zheng R, Zheng J, Francque S, Vanwolleghem T, Vonghia L, Manesis EK, Zoumpoulis P, Sporea I, Thiele M, Krag A, Cohen-Bacrie C, Criton A, Gay J, Deffieux T, Friedrich-Rust M. Assessment of biopsy-proven liver fibrosis by two-dimensional shear wave elastography: An individual patient data-based meta-analysis. Hepatology. 2018 Jan;67(1):260-272. doi: 10.1002/hep.29179. Epub 2017 Nov 15.
PubMed 28370257Castera L, Friedrich-Rust M, Loomba R. Noninvasive Assessment of Liver Disease in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 Apr;156(5):1264-1281.e4. doi: 10.1053/j.gastro.2018.12.036. Epub 2019 Jan 18.
PubMed 30660725Wang K, Lu X, Zhou H, Gao Y, Zheng J, Tong M, Wu C, Liu C, Huang L, Jiang T, Meng F, Lu Y, Ai H, Xie XY, Yin LP, Liang P, Tian J, Zheng R. Deep learning Radiomics of shear wave elastography significantly improved diagnostic performance for assessing liver fibrosis in chronic hepatitis B: a prospective multicentre study. Gut. 2019 Apr;68(4):729-741. doi: 10.1136/gutjnl-2018-316204. Epub 2018 May 5.
PubMed 29730602Procopet B, Berzigotti A, Abraldes JG, Turon F, Hernandez-Gea V, Garcia-Pagan JC, Bosch J. Real-time shear-wave elastography: applicability, reliability and accuracy for clinically significant portal hypertension. J Hepatol. 2015 May;62(5):1068-75. doi: 10.1016/j.jhep.2014.12.007. Epub 2014 Dec 13.
PubMed 25514554Elkrief L, Rautou PE, Ronot M, Lambert S, Dioguardi Burgio M, Francoz C, Plessier A, Durand F, Valla D, Lebrec D, Vilgrain V, Castera L. Prospective comparison of spleen and liver stiffness by using shear-wave and transient elastography for detection of portal hypertension in cirrhosis. Radiology. 2015 May;275(2):589-98. doi: 10.1148/radiol.14141210. Epub 2014 Nov 28.
PubMed 25469784Robic MA, Procopet B, Metivier S, Peron JM, Selves J, Vinel JP, Bureau C. Liver stiffness accurately predicts portal hypertension related complications in patients with chronic liver disease: a prospective study. J Hepatol. 2011 Nov;55(5):1017-24. doi: 10.1016/j.jhep.2011.01.051. Epub 2011 Feb 25.
PubMed 21354450de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736Cassinotto C, Lapuyade B, Guiu B, Marraud des Grottes H, Piron L, Merrouche W, Irles-Depe M, Molinari N, De Ledinghen V. Agreement Between 2-Dimensional Shear Wave and Transient Elastography Values for Diagnosis of Advanced Chronic Liver Disease. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2971-2979.e3. doi: 10.1016/j.cgh.2020.04.034. Epub 2020 Apr 26.
PubMed 32348907
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms
- ClinicalTrials.gov ID
- NCT06523608
- Acronym / sponsor ID
- DETECT / 2023-237-f-S
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to predict the short- and long-term development of acute severe disease events, de novo hepatocarcinoma (HCC) and mortality in patients with advanced chronic liver disease using the M10S20 (Liver stiffness and Model for End-Stage Liver Disease Score [MELD] combined) and PLEASE (Platelet, Etiology, Age, Sex und Elastography) scores, as well as the validation of the cost-effectiveness of the algorithm.
Patients in this study are randomly divided into two groups:
- Control group: patients are examined according to the current clinical standard protocol (biannual follow-up).
- Stratified surveillance program:
- High-risk patients will receive an appointment for a hospital visit every 3 months.
- Low-risk patients could receive an appointment in one year. When necessary, if decompensation develops or HCC occurs, patients could be followed-up more frequently.
Detailed description
Patients who are hospitalized with advanced chronic liver disease are randomly divided into two groups.
Patients in the control group are examined according to the current clinical standard protocol (biannual follow-up) or more frequently when decompensation or HCC develops.
Patients in the study group will be stratified for the risk of decompensation/mortality and de novo-HCC-risk, based on the M10S20 ([Liver stiffness and MELD combined]) and PLEASE ([Platelet, Etiology, Age, Sex und Elastography]) scores.
High-risk patients will be allocated for a further computer tomography (CT) or magnetic resonance imaging (MRI) examination and an alpha-fetoprotein (AFP) examination to exclude HCC and receive another appointment for a hospital visit within 3 months.
Low-risk patients could receive an appointment in one year. Patients in both arms, either outpatient or inpatient, will undergo at each visit an ultrasound examination with liver stiffness measurement and a routine blood test. Other examinations will be carried out according to standard medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, CT, MRI, endoscopies, bone marrow punctures, elastographies, transjugular intrahepatic portosystemic shunt (TIPS) implantations, operations, etc. will be performed as part of the usual diagnostic clarification.
Hepatic encephalopathy is a decompensation event that will be diagnosed based on the West-Haven criteria, the number-connection test, the flicker frequency analysis and electroencephalogram. Written consent is required for every admitted patient. Data protection concept: When a patient is enrolled in the study, a center-specific study ID is first assigned for the purpose of pseudonymization.
The data collected is documented in an Excel spreadsheet. The assignment of the center-specific study ID to the respective patient is only possible for the respective investigator (Prof. Dr. Trebicka) and his staff (study nurse). For statistical evaluations, an analysis-specific data table will be created, which can be processed with an appropriate statistics program.
Patients cannot be identified with the data collected and the scientific research that derives from it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Standard survillance protocolPatients in the control group are examined according to standard protocol (with a biannual follow-up) or more frequently when there is a development of decompensation or HCC. |
| Group with stratified surveillance | – | Other: Stratified survillance protocolPatients in the study group will be stratified for the risk of decompensation/mortality and de novo-HCC-risk, based on the M10S20 ([Liver stiffness and MELD combined]) and PLEASE ([Platelet, Etiology, Age, Sex und Elastography]) scores. High-risk patients are allocated for a further CT/MRI examination and an AFP examination to exclude HCC and receive another appointment for a hospital visit within 3 months. Low-risk patients receive an appointment in one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients should be included in the study if they are hospitalized with suspected chronic liver liver disease of viral and/or steatotic origin.
Key inclusion criteria (1 listed)
- The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria)
Key exclusion criteria (8 listed)
- Pregnancy
- Age <18
- Evidence of current malignancy except for non-melanocytic skin cancer
- Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (New York Heart Association (NYHA) > II); severe chronic pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) > III), severe neurological and psychiatric disorders).
- Human Immunodeficiency Virus (HIV) positive patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard survillance protocolPatients will be followed every 6 months. They will undergo at each visit an ultrasound examination including liver stiffness and a routine blood test, including AFP. Other examinations are carried out according to the standard of medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, computer tomography, MR-tomography, endoscopies, bone marrow punctures, elastographies, TIPS implantations, operations, etc. will be performed as part of the usual diagnostic clarification. | Other | Control group |
| Stratified survillance protocolBased on PLEASE and M10LS20 scores, patients will be followed every 3 or 12 months. Low-risk patients will be followed once per year, and high-risk patients every 3 months. They will undergo at each visit an ultrasound examination including liver stiffness and a routine blood test, including AFP. Other examinations are carried out according to the standard of medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, computer tomography, MR-tomography, endoscopies, bone marrow punctures, elastographies, TIPS implantations, operations, etc. will be performed as part of the usual diagnostic clarification. | Other | Group with stratified surveillance |
Primary outcome
Mortality
Time frame: 2 years
All-cause mortality rate and liver-related mortality rate
Liver transplantation
Time frame: 2 years
Incidence of liver transplantation during follow-up period and time until liver transplantation.
8 secondary outcomes
De novo HCC
Time frame: 2 years
Acute liver decompensations
Time frame: 2 years
Therapy in patients who develop HCC during follow-up
Time frame: 2 years
Analysis of cost-effectiveness of the new algorithm compared to the routine follow-up
Time frame: 2 years
Analysis of proteome and metabolome in patients included into the study
Time frame: 2 years
Analysis of intestinal and circulating microbiome in patients included into the study
Time frame: 2 years
Influence of circulating immune cells in HCC development and progression
Time frame: 2 years
Influence of transcriptome and metagenome in HCC development and progression
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 20638742de Franchis R; Baveno V Faculty. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2010 Oct;53(4):762-8. doi: 10.1016/j.jhep.2010.06.004. Epub 2010 Jun 27. No abstract available.
- Background: PubMed 11172350Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172.
- Background: PubMed 29059466Jansen C, Moller P, Meyer C, Kolbe CC, Bogs C, Pohlmann A, Schierwagen R, Praktiknjo M, Abdullah Z, Lehmann J, Thomas D, Strassburg CP, Latz E, Mueller S, Rossle M, Trebicka J. Increase in liver stiffness after transjugular intrahepatic portosystemic shunt is associated with inflammation and predicts mortality. Hepatology. 2018 Apr;67(4):1472-1484. doi: 10.1002/hep.29612. Epub 2018 Feb 20.
- Background: PubMed 29059469Praktiknjo M, Book M, Luetkens J, Pohlmann A, Meyer C, Thomas D, Jansen C, Feist A, Chang J, Grimm J, Lehmann J, Strassburg CP, Abraldes JG, Kukuk G, Trebicka J. Fat-free muscle mass in magnetic resonance imaging predicts acute-on-chronic liver failure and survival in decompensated cirrhosis. Hepatology. 2018 Mar;67(3):1014-1026. doi: 10.1002/hep.29602. Epub 2018 Jan 24.
- Background: PubMed 30739387Lehmann J, Praktiknjo M, Nielsen MJ, Schierwagen R, Meyer C, Thomas D, Violi F, Strassburg CP, Bendtsen F, Moller S, Krag A, Karsdal MA, Leeming DJ, Trebicka J. Collagen type IV remodelling gender-specifically predicts mortality in decompensated cirrhosis. Liver Int. 2019 May;39(5):885-893. doi: 10.1111/liv.14070. Epub 2019 Mar 7.
- Background: PubMed 29316310Luo X, Leanza J, Massie AB, Garonzik-Wang JM, Haugen CE, Gentry SE, Ottmann SE, Segev DL. MELD as a metric for survival benefit of liver transplantation. Am J Transplant. 2018 May;18(5):1231-1237. doi: 10.1111/ajt.14660. Epub 2018 Feb 19.
- Background: PubMed 26896458Jansen C, Bogs C, Verlinden W, Thiele M, Moller P, Gortzen J, Lehmann J, Praktiknjo M, Chang J, Krag A, Strassburg CP, Francque S, Trebicka J. Algorithm to rule out clinically significant portal hypertension combining Shear-wave elastography of liver and spleen: a prospective multicentre study. Gut. 2016 Jun;65(6):1057-8. doi: 10.1136/gutjnl-2016-311536. Epub 2016 Feb 19. No abstract available.
- Background: PubMed 28370257Herrmann E, de Ledinghen V, Cassinotto C, Chu WC, Leung VY, Ferraioli G, Filice C, Castera L, Vilgrain V, Ronot M, Dumortier J, Guibal A, Pol S, Trebicka J, Jansen C, Strassburg C, Zheng R, Zheng J, Francque S, Vanwolleghem T, Vonghia L, Manesis EK, Zoumpoulis P, Sporea I, Thiele M, Krag A, Cohen-Bacrie C, Criton A, Gay J, Deffieux T, Friedrich-Rust M. Assessment of biopsy-proven liver fibrosis by two-dimensional shear wave elastography: An individual patient data-based meta-analysis. Hepatology. 2018 Jan;67(1):260-272. doi: 10.1002/hep.29179. Epub 2017 Nov 15.
- Background: PubMed 30660725Castera L, Friedrich-Rust M, Loomba R. Noninvasive Assessment of Liver Disease in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 Apr;156(5):1264-1281.e4. doi: 10.1053/j.gastro.2018.12.036. Epub 2019 Jan 18.
- Background: PubMed 29730602Wang K, Lu X, Zhou H, Gao Y, Zheng J, Tong M, Wu C, Liu C, Huang L, Jiang T, Meng F, Lu Y, Ai H, Xie XY, Yin LP, Liang P, Tian J, Zheng R. Deep learning Radiomics of shear wave elastography significantly improved diagnostic performance for assessing liver fibrosis in chronic hepatitis B: a prospective multicentre study. Gut. 2019 Apr;68(4):729-741. doi: 10.1136/gutjnl-2018-316204. Epub 2018 May 5.
- Background: PubMed 25514554Procopet B, Berzigotti A, Abraldes JG, Turon F, Hernandez-Gea V, Garcia-Pagan JC, Bosch J. Real-time shear-wave elastography: applicability, reliability and accuracy for clinically significant portal hypertension. J Hepatol. 2015 May;62(5):1068-75. doi: 10.1016/j.jhep.2014.12.007. Epub 2014 Dec 13.
- Background: PubMed 25469784Elkrief L, Rautou PE, Ronot M, Lambert S, Dioguardi Burgio M, Francoz C, Plessier A, Durand F, Valla D, Lebrec D, Vilgrain V, Castera L. Prospective comparison of spleen and liver stiffness by using shear-wave and transient elastography for detection of portal hypertension in cirrhosis. Radiology. 2015 May;275(2):589-98. doi: 10.1148/radiol.14141210. Epub 2014 Nov 28.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonel Trebicka, Prof. Dr. med. principal investigator
Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany
Jonel Trebicka, Prof. Dr. med. principal investigator
European Foundation for Study of Chronic Liver Failure, Barcelona, Spain
Jonel Trebicka, Prof. Dr. med. principal investigator
Department of Gastroenterology and Hepatology, Odense University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Hepatocellular Carcinoma, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonel Trebicka, Prof. Dr. med. (+49 02518359689, jonel.trebicka@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06523608, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.