Relevance of Sarcopenia in Advanced Liver Disease

Trial Title: Relevance of Sarcopenia in Advanced Liver Disease

NCT ID: NCT05502198

Condition: Liver Cirrhosis
Hepatocellular Carcinoma
Sarcopenia
Portal Hypertension

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Diseases
Liver Cirrhosis
Hypertension, Portal
Sarcopenia
Hypertension

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Gastroenterology), District Hospital in Eksjö

Address:
City: Eksjö
Zip: 57581
Country: Sweden

Status: Recruiting

Contact:
Last name: Martin Rejler, PhD, MD
Email: martin.rejler@rjl.se

Contact backup:
Last name: Daniel Sjögren, MD
Email: daniel.sjogren@rjl.se

Investigator:
Last name: Martin Rejler, PhD, MD
Email: Principal Investigator

Investigator:
Last name: Daniel Sjögren, MD
Email: Sub-Investigator

Facility:
Name: Department of gastroenterology, County Hospital in Jönköping

Address:
City: Jönköping
Zip: 55185
Country: Sweden

Status: Recruiting

Contact:
Last name: Henrik Stjernman, PhD, MD
Email: henrik.stjernman@rjl.se

Investigator:
Last name: Henrik Stjernman, PhD, MD
Email: Principal Investigator

Facility:
Name: Department of gastroenterology and hepatology

Address:
City: Linköping
Country: Sweden

Status: Recruiting

Contact:
Last name: Camilla Holmgren

Phone: +46101030000
Email: camilla.holmgren@regionostergotland.se

Start date: February 1, 2021

Completion date: June 30, 2030

Lead sponsor:
Agency: Linkoeping University
Agency class: Other

Collaborator:
Agency: Amra Medical AB
Agency class: Industry

Source: Linkoeping University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05502198