Assessing muscle loss and liver health in patients with advanced liver disease
A Rapid, Non-invasive, Clinical Surveillance for CachExia, Sarcopenia, Portal Hypertension and Hepatocellular Carcinoma in End-Stage Liver Disease
This study is testing how muscle loss affects liver health in people with advanced liver disease by looking at their body composition and overall well-being over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Linkoeping University Government |
| Locations | 3 sites (Eksjö and 2 other locations) |
| Trial ID | NCT05502198 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with established liver cirrhosis to evaluate the prevalence of sarcopenia, portal hypertension, and liver cancer through a comprehensive magnetic resonance examination. Participants will undergo a series of assessments, including clinical evaluations, MRI scans, and quality of life measures over a period of approximately 24 months. The study aims to derive body composition profiles and other relevant health metrics to better understand the relationship between muscle loss and liver disease progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with established or probable liver cirrhosis.
Not a fit: Patients with contraindications for MRI, primary sclerosing cholangitis, diagnosed hepatic carcinoma, or those who have had a previous liver transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for patients with advanced liver disease, potentially reducing morbidity and mortality.
How similar studies have performed: Other studies have shown success in using MRI for assessing body composition in liver disease, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Eksjö and 2 other locations
- Department of Gastroenterology), District Hospital in Eksjö — Eksjö, Sweden (Recruiting)
- Department of gastroenterology, County Hospital in Jönköping — Jönköping, Sweden (Recruiting)
- Department of gastroenterology and hepatology — Linköping, Sweden (Recruiting)
Study contacts
- Principal investigator: Mattias Ekstedt, MD, PhD — Linkoeping University
- Study coordinator: Mattias Ekstedt, MD, PhD
- Email: mattias.ekstedt@liu.se
- Phone: +46709296267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.