Liver CirrhosisACCESS-ESLDNCT05502198
Relevance of Sarcopenia in Advanced Liver Disease
An observational study of Liver Cirrhosis and Hepatocellular Carcinoma, run by Linkoeping University at 3 sites in Sweden.
Trial summary
Patients with established liver cirrhosis, or end-stage liver disease (ESLD), are at high risk of developing liver cancer (hepatic carcinoma; HCC), portal hypertension, and sarcopenia, all which lead to significant morbidity and mortality. In this patient group the annual incidence of HCC is c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatocellular Carcinoma, Sarcopenia
- How many people
- 150 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Feb 2021to 30 Jun 2030
- 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: 150 patients with established or probable liver cirrhosis at the Department of Gastroenterology and Hepatology at Linköping University Hospital as well as collaborating hospitals; District Hospital in Eksjö and County Hospital in Jönköping, will be included in the study. All etiologies of cirrhosis will be included except patients with primary sclerosing cholangitis.
Who may be able to join
- Established or probable liver cirrhosis according to clinical practice at the Department of Gastroenterology and Hepatology at Linköping University Hospital. This is not by necessity biopsy verified, it can be different criteria such as FibroScan, symptoms, biopsy, and radiology.
- Age ≥18 years
- Written informed consent from the participant
Who cannot join
- Contraindications for MRI
- Subjects suffering from primary sclerosing cholangitis (PSC)
- Subjects diagnosed with Hepatic carcinoma (HCC)
- Previous liver transplant
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mikael Forsgren, PhD contact
Sweden3 sites, 3 recruiting
- Recruiting
Department of Gastroenterology), District Hospital in Eksjö
Eksjö, 57581
Martin Rejler, PhD, MD, martin.rejler@rjl.se
Daniel Sjögren, MD, daniel.sjogren@rjl.se
- Recruiting
Department of gastroenterology, County Hospital in Jönköping
Jönköping, 55185
Henrik Stjernman, PhD, MD, henrik.stjernman@rjl.se
Henrik Stjernman, PhD, MD
- Recruiting
Department of gastroenterology and hepatology
Linköping
Camilla Holmgren, +46101030000, camilla.holmgren@regionostergotland.se
About this study
Official title: A Rapid, Non-invasive, Clinical Surveillance for CachExia, Sarcopenia, Portal Hypertension and Hepatocellular Carcinoma in End-Stage Liver Disease
Patients with established liver cirrhosis, or end-stage liver disease (ESLD), are at high risk of developing liver cancer (hepatic carcinoma; HCC), portal hypertension, and sarcopenia, all which lead to significant morbidity and mortality. In this patient group the annual incidence of HCC is c. 2-8% and these patients are therefore included in ultrasound HCC screening programs every 6 months.
In this study, the investigators are aiming to assess sarcopenia, clinically significant portal hypertension (CSPH), and HCC with a single short magnetic resonance (MR) examination. A neck-to-knee MRI-examination will be acquired to derive body composition profile (BCP) measurements including visceral and abdominal subcutaneous adipose tissue (VAT and ASAT), thigh fat free muscle volume (FFMV) and muscle fat infiltration (MFI), as well as liver fat (PDFF), spleen volume, and liver stiffness. Images will be further processed by AMRA Medical AB. AMRA's solution includes FFMV in the context of virtual control groups (VCG; using AMRA's vast database) and MFI. Furthermore, the spleen volume will be used to monitor the development of portal hypertension and explored together with other BCP variables in relation to hepatic decompensation events. HCC screening will be performed using so-called abbreviated MRI (AMRI), which consists of time series of contrast-enhanced T1-weighted images. The AMRI images will be read by an experienced radiologist. In the literature the sensitivity of AMRI to detect HCC is above 80%, with a specificity of c. 95%, compared to ultrasound sensitivity of 60%.
In treating ESLD there is a desire of physicians to be able to predict future decompensation events in order to initiate treatment to prolong survival. Moreover, the ability to assess processes of sarcopenia in the patient would be highly valuable for clinical practice due its severe clinical impact. Finally, ultrasound-based HCC screening has poor diagnostic performance and a MR-based screening approach would significantly improve treatment outcome as more treatable and earlier HCC may be identified.
Read the detailed description
150 patients with established or probable liver cirrhosis at the Department of Gastroenterology and Hepatology at Linköping University Hospital, as well as collaborating hospitals; District Hospital in Eksjö and County Hospital in Jönköping, will be included in the study. The study includes four visits every six months (in patients with LI-RADS 3 five visits will be performed); each patient participates actively in the study during a time period of approximately 24 months. All study visits are scheduled in conjunction with clinical routine visits.
During each study visit the following is performed:
- A detailed clinical work-up
- Assessment of medical history or changes in health status since last visit
- FibroScan
- Magnetic resonance (MR) examination
- Comprehensive blood panels and blood samples for research
- Muscle function and mobility assessments (SPPB and hand grip strength).
- Quality of life assessment (EQ-5D-5L, QLDQ-cirrhosis and SHS-liver).
- Hepatic encephalopathy assessment (ANT test).
- Assessment of the development of symptoms
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Sarcopenia, Hypertension, Portal
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition (FFMVvcg)
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Measured: Baseline
Body composition (FFMVvcg)
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Measured: 6 months
Body composition (FFMVvcg)
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Measured: 1 year
Body composition (FFMVvcg)
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Measured: 18 months
Change from baseline Body composition (FFMVvcg)
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Measured: 6 months
Change from 6 months Body composition (FFMVvcg)
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Measured: 1 year
Change from 1 year Body composition (FFMVvcg)
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Measured: 18 months
Muscle fat infiltration (%) [MFI]
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Measured: Baseline
Muscle fat infiltration (%) [MFI]
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Measured: 6 months
Muscle fat infiltration (%) [MFI]
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Measured: 1 year
Muscle fat infiltration (%) [MFI]
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Measured: 18 months
Change from baseline Muscle fat infiltration (%) [MFI]
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Measured: 6 months
Change from 6 months Muscle fat infiltration (%) [MFI]
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Measured: 1 year
Change from 1 year Muscle fat infiltration (%) [MFI]
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Measured: 18 months
Presence of previous decompensation
If the patient previously has had ascites, bleeding esophageal varices, or encephalopathy.
Measured: Baseline
New episode of decompensation since baseline
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
Measured: 6 months
New episode of decompensation since 6 months
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
Measured: 1 year
New episode of decompensation since 1 year
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
Measured: 18 months
New episode of decompensation since 18 months
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
Measured: 2 years
Hepatocellular carcinoma
Detection of HCC by AMRI
Measured: Baseline
Significant liver lesion
LI-RADS 3-5
Measured: Baseline
Significant liver lesion
LI-RADS 3-5
Measured: 6 months
Significant liver lesion
LI-RADS 3-5
Measured: 1 year
Significant liver lesion
LI-RADS 3-5
Measured: 18 months
Hepatocellular carcinoma
Detection of HCC by AMRI
Measured: 6 months
Hepatocellular carcinoma
Detection of HCC by AMRI
Measured: 1 year
Hepatocellular carcinoma
Detection of HCC by AMRI
Measured: 18 months
Hepatocellular carcinoma
Chart review
Measured: 2 years
Hand grip strength (kg)
Measured at each visit with a hand-grip dynamometer
Measured: Baseline
Hand grip strength (kg)
Measured at each visit with a hand-grip dynamometer
Measured: 6 months
Hand grip strength (kg)
Measured at each visit with a hand-grip dynamometer
Measured: 1 year
Hand grip strength (kg)
Measured at each visit with a hand-grip dynamometer
Measured: 18 months
Muscle function
Measured using the validated Short Physical Performance Battery.
Measured: Baseline
Muscle function
Measured using the validated Short Physical Performance Battery.
Measured: 6 months
Muscle function
Measured using the validated Short Physical Performance Battery.
Measured: 1 year
Muscle function
Measured using the validated Short Physical Performance Battery.
Measured: 18 months
Child-Pugh score
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Measured: Baseline
Child-Pugh score
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Measured: 6 months
Child-Pugh score
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Measured: 1 year
Child-Pugh score
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Measured: 18 months
Child-Pugh score
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Measured: 2 year
MELD-score
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
Measured: Baseline
MELD-score
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
Measured: 6 months
MELD-score
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
Measured: 1 year
MELD-score
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
Measured: 18 months
MELD-score
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
Measured: 2 years
Secondary outcomes (29)
Death
Chart review
Measured: 6 months
Death
Chart review
Measured: 1 year
Death
Chart review
Measured: 18 months
Death
Chart review
Measured: 2 years
Esophageal varices
Assessed by gastroscopy and captured through chart review.
Measured: Baseline
Development of Esophageal varices
Assessed by gastroscopy and captured through chart review.
Measured: 6 months
Development of Esophageal varices
Assessed by gastroscopy and captured through chart review.
Measured: 1year
Development of Esophageal varices
Assessed by gastroscopy and captured through chart review.
Measured: 18 months
Development of Esophageal varices
Assessed by gastroscopy and captured through chart review.
Measured: 2 years
Liver stiffness by Fibroscan (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: Baseline
Liver stiffness by Fibroscan (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: 6 months
Liver stiffness by Fibroscan (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: 1 year
Liver stiffness by Fibroscan (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: 18 months
Liver stiffness by MRE (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: Baseline
Liver stiffness by MRE (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: 6 months
Liver stiffness by MRE (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: 1 year
Liver stiffness by MRE (kPa)
Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Measured: 18 months
Spleen volume (ml)
A surrogate marker for portal hypertension and measured by MR.
Measured: Baseline
Spleen volume (ml)
A surrogate marker for portal hypertension and measured by MR.
Measured: 6 months
Spleen volume (ml)
A surrogate marker for portal hypertension and measured by MR.
Measured: 1 year
Spleen volume (ml)
A surrogate marker for portal hypertension and measured by MR.
Measured: 18 months
Quality of life (Questionnaire)
EQ-5D-5L
Measured: Baseline
Quality of life (Questionnaire)
EQ-5D-5L
Measured: 6 months
Quality of life (Questionnaire)
EQ-5D-5L
Measured: 1 year
Quality of life (Questionnaire)
EQ-5D-5L
Measured: 18 months
Quality of life (Questionnaire)
Short Health Scale-liver
Measured: Baseline
Quality of life (Questionnaire)
Short Health Scale-liver
Measured: 6 months
Quality of life (Questionnaire)
Short Health Scale-liver
Measured: 1 year
Quality of life (Questionnaire)
Short Health Scale-liver
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Feb 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Amra Medical AB
- Responsible party
- Principal investigator, Mattias Ekstedt, Linkoeping University
- Investigators
- Mattias Ekstedt, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502198
- Sponsor's protocol ID
- 2020-07215
- Acronym
- ACCESS-ESLD
- Status last verified
- Aug 2023
- First submitted
- 15 Feb 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Forsgren MF, Sjogren D, Stjernman H, Nasr P, Balkhed W, Cederborg A, Holmberg M, Bartholoma W, Jonsson C, Lundberg P, Rejler M, Dahlstrom N, Kechagias S, Leinhard OD, Ekstedt M. Prevalence and Significance of Combined Low Muscle Volume and High Muscle Fat in Patients with Child-Pugh A-B Cirrhosis. JHEP Rep. 2026 Sep 11:102031. doi: 10.1016/j.jhepr.2026.102031. Online ahead of print.
PubMed 42727707Nasr P, Forsgren M, Balkhed W, Jonsson C, Dahlstrom N, Simonsson C, Cai S, Cederborg A, Henriksson M, Stjernman H, Rejler M, Sjogren D, Cedersund G, Bartholoma W, Ryden I, Lundberg P, Kechagias S, Leinhard OD, Ekstedt M. A rapid, non-invasive, clinical surveillance for CachExia, sarcopenia, portal hypertension, and hepatocellular carcinoma in end-stage liver disease: the ACCESS-ESLD study protocol. BMC Gastroenterol. 2023 Dec 21;23(1):454. doi: 10.1186/s12876-023-03093-8.
PubMed 38129794
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rapid, Non-invasive, Clinical Surveillance for CachExia, Sarcopenia, Portal Hypertension and Hepatocellular Carcinoma in End-Stage Liver Disease
- ClinicalTrials.gov ID
- NCT05502198
- Acronym / sponsor ID
- ACCESS-ESLD / 2020-07215
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Amra Medical AB
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 16 Aug 2022 (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.
Patients with established liver cirrhosis, or end-stage liver disease (ESLD), are at high risk of developing liver cancer (hepatic carcinoma; HCC), portal hypertension, and sarcopenia, all which lead to significant morbidity and mortality. In this patient group the annual incidence of HCC is c. 2-8% and these patients are therefore included in ultrasound HCC screening programs every 6 months.
In this study, the investigators are aiming to assess sarcopenia, clinically significant portal hypertension (CSPH), and HCC with a single short magnetic resonance (MR) examination. A neck-to-knee MRI-examination will be acquired to derive body composition profile (BCP) measurements including visceral and abdominal subcutaneous adipose tissue (VAT and ASAT), thigh fat free muscle volume (FFMV) and muscle fat infiltration (MFI), as well as liver fat (PDFF), spleen volume, and liver stiffness. Images will be further processed by AMRA Medical AB. AMRA's solution includes FFMV in the context of virtual control groups (VCG; using AMRA's vast database) and MFI. Furthermore, the spleen volume will be used to monitor the development of portal hypertension and explored together with other BCP variables in relation to hepatic decompensation events. HCC screening will be performed using so-called abbreviated MRI (AMRI), which consists of time series of contrast-enhanced T1-weighted images. The AMRI images will be read by an experienced radiologist. In the literature the sensitivity of AMRI to detect HCC is above 80%, with a specificity of c. 95%, compared to ultrasound sensitivity of 60%.
In treating ESLD there is a desire of physicians to be able to predict future decompensation events in order to initiate treatment to prolong survival. Moreover, the ability to assess processes of sarcopenia in the patient would be highly valuable for clinical practice due its severe clinical impact. Finally, ultrasound-based HCC screening has poor diagnostic performance and a MR-based screening approach would significantly improve treatment outcome as more treatable and earlier HCC may be identified.
Detailed description
150 patients with established or probable liver cirrhosis at the Department of Gastroenterology and Hepatology at Linköping University Hospital, as well as collaborating hospitals; District Hospital in Eksjö and County Hospital in Jönköping, will be included in the study. The study includes four visits every six months (in patients with LI-RADS 3 five visits will be performed); each patient participates actively in the study during a time period of approximately 24 months. All study visits are scheduled in conjunction with clinical routine visits.
During each study visit the following is performed:
- A detailed clinical work-up
- Assessment of medical history or changes in health status since last visit
- FibroScan
- Magnetic resonance (MR) examination
- Comprehensive blood panels and blood samples for research
- Muscle function and mobility assessments (SPPB and hand grip strength).
- Quality of life assessment (EQ-5D-5L, QLDQ-cirrhosis and SHS-liver).
- Hepatic encephalopathy assessment (ANT test).
- Assessment of the development of symptoms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with established or probable liver cirrhosis at the Department of Gastroenterology and Hepatology at Linköping University Hospital as well as collaborating hospitals; District Hospital in Eksjö and County Hospital in Jönköping, will be included in the study. All etiologies of cirrhosis will be included except patients with primary sclerosing cholangitis.
Key inclusion criteria (3 listed)
- Established or probable liver cirrhosis according to clinical practice at the Department of Gastroenterology and Hepatology at Linköping University Hospital. This is not by necessity biopsy verified, it can be different criteria such as FibroScan, symptoms, biopsy, and radiology.
- Age ≥18 years
- Written informed consent from the participant
Key exclusion criteria (4 listed)
- Contraindications for MRI
- Subjects suffering from primary sclerosing cholangitis (PSC)
- Subjects diagnosed with Hepatic carcinoma (HCC)
- Previous liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body composition (FFMVvcg)
Time frame: Baseline
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Body composition (FFMVvcg)
Time frame: 6 months
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Body composition (FFMVvcg)
Time frame: 1 year
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Body composition (FFMVvcg)
Time frame: 18 months
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Change from baseline Body composition (FFMVvcg)
Time frame: 6 months
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Change from 6 months Body composition (FFMVvcg)
Time frame: 1 year
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Change from 1 year Body composition (FFMVvcg)
Time frame: 18 months
FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.
Muscle fat infiltration (%) [MFI]
Time frame: Baseline
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Muscle fat infiltration (%) [MFI]
Time frame: 6 months
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Muscle fat infiltration (%) [MFI]
Time frame: 1 year
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Muscle fat infiltration (%) [MFI]
Time frame: 18 months
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Change from baseline Muscle fat infiltration (%) [MFI]
Time frame: 6 months
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Change from 6 months Muscle fat infiltration (%) [MFI]
Time frame: 1 year
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Change from 1 year Muscle fat infiltration (%) [MFI]
Time frame: 18 months
MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Presence of previous decompensation
Time frame: Baseline
If the patient previously has had ascites, bleeding esophageal varices, or encephalopathy.
New episode of decompensation since baseline
Time frame: 6 months
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
New episode of decompensation since 6 months
Time frame: 1 year
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
New episode of decompensation since 1 year
Time frame: 18 months
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
New episode of decompensation since 18 months
Time frame: 2 years
If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
Hepatocellular carcinoma
Time frame: Baseline
Detection of HCC by AMRI
Significant liver lesion
Time frame: Baseline
LI-RADS 3-5
Significant liver lesion
Time frame: 6 months
LI-RADS 3-5
Significant liver lesion
Time frame: 1 year
LI-RADS 3-5
Significant liver lesion
Time frame: 18 months
LI-RADS 3-5
Hepatocellular carcinoma
Time frame: 6 months
Detection of HCC by AMRI
Hepatocellular carcinoma
Time frame: 1 year
Detection of HCC by AMRI
Hepatocellular carcinoma
Time frame: 18 months
Detection of HCC by AMRI
Hepatocellular carcinoma
Time frame: 2 years
Chart review
Hand grip strength (kg)
Time frame: Baseline
Measured at each visit with a hand-grip dynamometer
Hand grip strength (kg)
Time frame: 6 months
Measured at each visit with a hand-grip dynamometer
Hand grip strength (kg)
Time frame: 1 year
Measured at each visit with a hand-grip dynamometer
Hand grip strength (kg)
Time frame: 18 months
Measured at each visit with a hand-grip dynamometer
Muscle function
Time frame: Baseline
Measured using the validated Short Physical Performance Battery.
Muscle function
Time frame: 6 months
Measured using the validated Short Physical Performance Battery.
Muscle function
Time frame: 1 year
Measured using the validated Short Physical Performance Battery.
Muscle function
Time frame: 18 months
Measured using the validated Short Physical Performance Battery.
Child-Pugh score
Time frame: Baseline
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Child-Pugh score
Time frame: 6 months
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Child-Pugh score
Time frame: 1 year
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Child-Pugh score
Time frame: 18 months
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Child-Pugh score
Time frame: 2 year
A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
MELD-score
Time frame: Baseline
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
MELD-score
Time frame: 6 months
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
MELD-score
Time frame: 1 year
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
MELD-score
Time frame: 18 months
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
MELD-score
Time frame: 2 years
A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
29 secondary outcomes
Death
Time frame: 6 months
Death
Time frame: 1 year
Death
Time frame: 18 months
Death
Time frame: 2 years
Esophageal varices
Time frame: Baseline
Development of Esophageal varices
Time frame: 6 months
Development of Esophageal varices
Time frame: 1year
Development of Esophageal varices
Time frame: 18 months
Development of Esophageal varices
Time frame: 2 years
Liver stiffness by Fibroscan (kPa)
Time frame: Baseline
Liver stiffness by Fibroscan (kPa)
Time frame: 6 months
Liver stiffness by Fibroscan (kPa)
Time frame: 1 year
Liver stiffness by Fibroscan (kPa)
Time frame: 18 months
Liver stiffness by MRE (kPa)
Time frame: Baseline
Liver stiffness by MRE (kPa)
Time frame: 6 months
Liver stiffness by MRE (kPa)
Time frame: 1 year
Liver stiffness by MRE (kPa)
Time frame: 18 months
Spleen volume (ml)
Time frame: Baseline
Spleen volume (ml)
Time frame: 6 months
Spleen volume (ml)
Time frame: 1 year
Spleen volume (ml)
Time frame: 18 months
Quality of life (Questionnaire)
Time frame: Baseline
Quality of life (Questionnaire)
Time frame: 6 months
Quality of life (Questionnaire)
Time frame: 1 year
Quality of life (Questionnaire)
Time frame: 18 months
Quality of life (Questionnaire)
Time frame: Baseline
Quality of life (Questionnaire)
Time frame: 6 months
Quality of life (Questionnaire)
Time frame: 1 year
Quality of life (Questionnaire)
Time frame: 18 months
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 24 Aug 2023.
- Derived from this study: PubMed 42727707Forsgren MF, Sjogren D, Stjernman H, Nasr P, Balkhed W, Cederborg A, Holmberg M, Bartholoma W, Jonsson C, Lundberg P, Rejler M, Dahlstrom N, Kechagias S, Leinhard OD, Ekstedt M. Prevalence and Significance of Combined Low Muscle Volume and High Muscle Fat in Patients with Child-Pugh A-B Cirrhosis. JHEP Rep. 2026 Sep 11:102031. doi: 10.1016/j.jhepr.2026.102031. Online ahead of print.
- Derived from this study: PubMed 38129794Nasr P, Forsgren M, Balkhed W, Jonsson C, Dahlstrom N, Simonsson C, Cai S, Cederborg A, Henriksson M, Stjernman H, Rejler M, Sjogren D, Cedersund G, Bartholoma W, Ryden I, Lundberg P, Kechagias S, Leinhard OD, Ekstedt M. A rapid, non-invasive, clinical surveillance for CachExia, sarcopenia, portal hypertension, and hepatocellular carcinoma in end-stage liver disease: the ACCESS-ESLD study protocol. BMC Gastroenterol. 2023 Dec 21;23(1):454. doi: 10.1186/s12876-023-03093-8.
- Individual participant dataSharing planned: Undecided
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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.
Mikael Forsgren, PhD contact
Mattias Ekstedt, MD, PhD principal investigator
Linkoeping University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Hepatocellular Carcinoma, run by Linkoeping University at 3 sites in Sweden.
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 3 inclusion and 4 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 Mattias Ekstedt, MD, PhD (+46709296267, mattias.ekstedt@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (FFMVvcg) (time frame: Baseline). The study lists 46 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 NCT05502198, which also lists 2 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 24 Aug 2023.