Relevance of Sarcopenia in Advanced Liver Disease

Recruiting now

Conditions studied: Liver Cirrhosis, Hepatocellular Carcinoma, Sarcopenia, Portal Hypertension

In brief

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.

Key facts

Study ID

NCT05502198

Run by

Linkoeping University

People needed

150

Starts

2021-02-01

Expected to finish

2030-06-30

Last updated by the study team

2023-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Contraindications for MRI
• Subjects suffering from primary sclerosing cholangitis (PSC)
• Subjects diagnosed with Hepatic carcinoma (HCC)
• Previous liver transplant

Where it is running

• Department of Gastroenterology), District Hospital in Eksjö — Eksjö, Sweden (enrolling)
• Department of gastroenterology, County Hospital in Jönköping — Jönköping, Sweden (enrolling)
• Department of gastroenterology and hepatology — Linköping, Sweden (enrolling)

Full record on ClinicalTrials.gov

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