Skip to content

Relevance of Sarcopenia in Advanced Liver Disease

A Rapid, Non-invasive, Clinical Surveillance for CachExia, Sarcopenia, Portal Hypertension and Hepatocellular Carcinoma in End-Stage Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05502198
Acronym
ACCESS-ESLD
Enrollment
150
Registered
2022-08-16
Start date
2021-02-01
Completion date
2030-06-30
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Liver Cirrhosis, Portal Hypertension, Sarcopenia

Brief 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. 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

Interventions

None listed

Sponsors

Amra Medical AB
CollaboratorINDUSTRY
Linkoeping University
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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. 2. Age ≥18 years 3. Written informed consent from the participant

Exclusion criteria

1. Contraindications for MRI 2. Subjects suffering from primary sclerosing cholangitis (PSC) 3. Subjects diagnosed with Hepatic carcinoma (HCC) 4. Previous liver transplant

Design outcomes

Primary

MeasureTime frameDescription
MELD-scoreBaselineA validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium
New episode of decompensation since 1 year18 monthsIf the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
New episode of decompensation since 18 months2 yearsIf the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
Hepatocellular carcinomaBaselineDetection of HCC by AMRI
Significant liver lesionBaselineLI-RADS 3-5
Hand grip strength (kg)BaselineMeasured at each visit with a hand-grip dynamometer
Muscle functionBaselineMeasured using the validated Short Physical Performance Battery.
Child-Pugh scoreBaselineA validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy
Body composition (FFMVvcg)BaselineFFMVvcg 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)6 monthsFFMVvcg 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)1 yearFFMVvcg 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)18 monthsFFMVvcg 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]BaselineMFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Change from baseline Muscle fat infiltration (%) [MFI]6 monthsMFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Change from 6 months Muscle fat infiltration (%) [MFI]1 yearMFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Change from 1 year Muscle fat infiltration (%) [MFI]18 monthsMFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).
Presence of previous decompensationBaselineIf the patient previously has had ascites, bleeding esophageal varices, or encephalopathy.
New episode of decompensation since baseline6 monthsIf the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.
New episode of decompensation since 6 months1 yearIf the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.

Secondary

MeasureTime frameDescription
Esophageal varicesBaselineAssessed by gastroscopy and captured through chart review.
Development of Esophageal varices6 monthsAssessed by gastroscopy and captured through chart review.
Liver stiffness by Fibroscan (kPa)BaselineLiver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Liver stiffness by MRE (kPa)BaselineLiver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.
Spleen volume (ml)BaselineA surrogate marker for portal hypertension and measured by MR.
Quality of life (Questionnaire)BaselineEQ-5D-5L
Death6 monthsChart review

Countries

Sweden

Contacts

Primary ContactMattias Ekstedt, MD, PhD
mattias.ekstedt@liu.se+46709296267
Backup ContactMikael Forsgren, PhD
mikael.forsgren@amramedical.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 13, 2026