Muscles in Liver Diseases (UNIVERSE)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Patients Having a Scheduled Abdominal Surgery Procedure

Treatments: Other: biopsy of abdominal paroie; Other: blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04758793

APHP201215

Details and patient eligibility

About

Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.

Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.

This study, carried out on a prospective cohort of patients with liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.

Full description

Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, and chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.

Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.

This study, carried out on a prospective cohort of patients with stable liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.

After checking the inclusion criteria, all eligible patients treated at Beaujon Hospital (Clichy) will be invited to participate in the study. After inclusion, clinical and laboratory features (hepatic assessment) will be collected and the blood samples will be taken.

During the surgery, a muscle biopsy will be performed on the incision area. No follow-up is planned.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over the age of 18 having a scheduled abdominal surgery at Beaujon Hospital
• Patient affiliated to a social security scheme
• Informed patient having signed a consent to participate

Exclusion criteria

Primary muscle disease (myopathy, dermatopolymyositis, vasculitis with muscle involvement)

• Amyotrophic drugs: long-term corticosteroid therapy
• Immunosuppressive treatments
• Chronic inflammatory disease (example: Crohn's disease)
• Disease known to cause sarcopenia such as -but not limited to- active extrahepatic neoplasia, polycystic hepatorenal disease
• Gastrointestinal haemorrhage in the 15 days prior to inclusion
• Acute alcoholic hepatitis in the month before inclusion
• Infection during treatment
• Pregnant or breastfeeding woman
• Protected populations: people under guardianship or under guardianship
• Patient not affiliated to a social security scheme
• Patient under AME
• Patient not having signed consent

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 4 patient groups

patients without liver disease,

Other group

Description:

taking blood samples and biopsy of muscular wall

Treatment:

Other: biopsy of abdominal paroie

Other: blood samples

patient with chronic liver disease without cirrhosis,

Other group

Description:

taking blood samples and biopsy of muscular wall

Treatment:

Other: biopsy of abdominal paroie

Other: blood samples

patients with compensated cirrhosis,

Other group

Description:

taking blood samples and biopsy of muscular wall

Treatment:

Other: biopsy of abdominal paroie

Other: blood samples

patient with severe cirrhosis

Other group

Description:

taking blood samples and biopsy of muscular wall

Treatment:

Other: biopsy of abdominal paroie

Other: blood samples