Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05502198

Relevance of Sarcopenia in Advanced 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Liver Cirrhosis Adenocarcinoma Atrophy Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Fibrosis Hepatocellular Carcinoma Hypertension, Portal Liver Diseases Liver Neoplasms Muscular Atrophy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Portal Hypertension Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology), District Hospital in Eksjö, Eksjö, Sweden

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Muscle fat infiltration (%) [MFI]

    Time frame: Baseline

    MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).

  9. Muscle fat infiltration (%) [MFI]

    Time frame: 6 months

    MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).

  10. Muscle fat infiltration (%) [MFI]

    Time frame: 1 year

    MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).

  11. Muscle fat infiltration (%) [MFI]

    Time frame: 18 months

    MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).

  12. 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 (%).

  13. 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 (%).

  14. 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 (%).

  15. Presence of previous decompensation

    Time frame: Baseline

    If the patient previously has had ascites, bleeding esophageal varices, or encephalopathy.

  16. New episode of decompensation since baseline

    Time frame: 6 months

    If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.

  17. 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.

  18. 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.

  19. 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.

  20. Hepatocellular carcinoma

    Time frame: Baseline

    Detection of HCC by AMRI

  21. Significant liver lesion

    Time frame: Baseline

    LI-RADS 3-5

  22. Significant liver lesion

    Time frame: 6 months

    LI-RADS 3-5

  23. Significant liver lesion

    Time frame: 1 year

    LI-RADS 3-5

  24. Significant liver lesion

    Time frame: 18 months

    LI-RADS 3-5

  25. Hepatocellular carcinoma

    Time frame: 6 months

    Detection of HCC by AMRI

  26. Hepatocellular carcinoma

    Time frame: 1 year

    Detection of HCC by AMRI

  27. Hepatocellular carcinoma

    Time frame: 18 months

    Detection of HCC by AMRI

  28. Hepatocellular carcinoma

    Time frame: 2 years

    Chart review

  29. Hand grip strength (kg)

    Time frame: Baseline

    Measured at each visit with a hand-grip dynamometer

  30. Hand grip strength (kg)

    Time frame: 6 months

    Measured at each visit with a hand-grip dynamometer

  31. Hand grip strength (kg)

    Time frame: 1 year

    Measured at each visit with a hand-grip dynamometer

  32. Hand grip strength (kg)

    Time frame: 18 months

    Measured at each visit with a hand-grip dynamometer

  33. Muscle function

    Time frame: Baseline

    Measured using the validated Short Physical Performance Battery.

  34. Muscle function

    Time frame: 6 months

    Measured using the validated Short Physical Performance Battery.

  35. Muscle function

    Time frame: 1 year

    Measured using the validated Short Physical Performance Battery.

  36. Muscle function

    Time frame: 18 months

    Measured using the validated Short Physical Performance Battery.

  37. Child-Pugh score

    Time frame: Baseline

    A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy

  38. Child-Pugh score

    Time frame: 6 months

    A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy

  39. Child-Pugh score

    Time frame: 1 year

    A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy

  40. Child-Pugh score

    Time frame: 18 months

    A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy

  41. Child-Pugh score

    Time frame: 2 year

    A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy

  42. MELD-score

    Time frame: Baseline

    A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium

  43. MELD-score

    Time frame: 6 months

    A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium

  44. MELD-score

    Time frame: 1 year

    A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium

  45. MELD-score

    Time frame: 18 months

    A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium

  46. MELD-score

    Time frame: 2 years

    A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium

Secondary outcomes

  1. Death

    Time frame: 6 months

    Chart review

  2. Death

    Time frame: 1 year

    Chart review

  3. Death

    Time frame: 18 months

    Chart review

  4. Death

    Time frame: 2 years

    Chart review

  5. Esophageal varices

    Time frame: Baseline

    Assessed by gastroscopy and captured through chart review.

  6. Development of Esophageal varices

    Time frame: 6 months

    Assessed by gastroscopy and captured through chart review.

  7. Development of Esophageal varices

    Time frame: 1year

    Assessed by gastroscopy and captured through chart review.

  8. Development of Esophageal varices

    Time frame: 18 months

    Assessed by gastroscopy and captured through chart review.

  9. Development of Esophageal varices

    Time frame: 2 years

    Assessed by gastroscopy and captured through chart review.

  10. Liver stiffness by Fibroscan (kPa)

    Time frame: Baseline

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  11. Liver stiffness by Fibroscan (kPa)

    Time frame: 6 months

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  12. Liver stiffness by Fibroscan (kPa)

    Time frame: 1 year

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  13. Liver stiffness by Fibroscan (kPa)

    Time frame: 18 months

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  14. Liver stiffness by MRE (kPa)

    Time frame: Baseline

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  15. Liver stiffness by MRE (kPa)

    Time frame: 6 months

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  16. Liver stiffness by MRE (kPa)

    Time frame: 1 year

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  17. Liver stiffness by MRE (kPa)

    Time frame: 18 months

    Liver stiffness is a surrogate marker for fibrosis stage, portal hypertension, and a prognostic marker.

  18. Spleen volume (ml)

    Time frame: Baseline

    A surrogate marker for portal hypertension and measured by MR.

  19. Spleen volume (ml)

    Time frame: 6 months

    A surrogate marker for portal hypertension and measured by MR.

  20. Spleen volume (ml)

    Time frame: 1 year

    A surrogate marker for portal hypertension and measured by MR.

  21. Spleen volume (ml)

    Time frame: 18 months

    A surrogate marker for portal hypertension and measured by MR.

  22. Quality of life (Questionnaire)

    Time frame: Baseline

    EQ-5D-5L

  23. Quality of life (Questionnaire)

    Time frame: 6 months

    EQ-5D-5L

  24. Quality of life (Questionnaire)

    Time frame: 1 year

    EQ-5D-5L

  25. Quality of life (Questionnaire)

    Time frame: 18 months

    EQ-5D-5L

  26. Quality of life (Questionnaire)

    Time frame: Baseline

    Short Health Scale-liver

  27. Quality of life (Questionnaire)

    Time frame: 6 months

    Short Health Scale-liver

  28. Quality of life (Questionnaire)

    Time frame: 1 year

    Short Health Scale-liver

  29. Quality of life (Questionnaire)

    Time frame: 18 months

    Short Health Scale-liver

Study contacts

Contact information is provided by the study sponsor or research team.

Mattias Ekstedt, MD, PhD

CONTACT

[email protected]

+46709296267

Mikael Forsgren, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Amra Medical AB

Registry information

Official study title

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

Acronym: ACCESS-ESLD

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Aug 16, 2022
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.