Patients Having a Scheduled Abdominal Surgery Procedure Clinical Trial
— UNIVERSEOfficial title:
Muscles in Liver Diseases
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.
| Status | Not yet recruiting |
| Enrollment | 260 |
| Est. completion date | May 31, 2026 |
| Est. primary completion date | May 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | describe the muscle changes that occur during liver disease. | Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers | 1 month after the of inclusion | |
| Primary | describe the muscle changes that occur during liver disease. | Assessment of the histology of the muscle removed during abdominal surgery, by evaluating the vascularity with measurements of CD31 count and aSMA count | 1 month after the of inclusion | |
| Primary | describe the muscle changes that occur during liver disease. | Assessment of the histology of the muscle removed during abdominal surgery by evaluating the muscle stem cells with measurements of Pax7, MyoD and Myogenin | 1 month after the of inclusion | |
| Primary | describe the muscle changes that occur during liver disease. | Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics | 1 month after the of inclusion | |
| Secondary | Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle. | Circulating concentration of mediators / cells suspected of being responsible for sarcopenia:
extracellular vesicles released by the liver lymphocyte phenotype potentially modified by sinusoidal endothelial cells of the liver protein array |
1 month after the of inclusion | |
| Secondary | Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs | Circulating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease:
extracellular vesicles myokines |
1 month after the of inclusion |