Patients Having a Scheduled Abdominal Surgery ProcedureUNIVERSENCT04758793
Muscles in Liver Diseases
A study testing blood samples and biopsy of abdominal paroie in people with Patients Having a Scheduled Abdominal Surgery Procedure, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Having a Scheduled Abdominal Surgery Procedure
- What is being tested?
- blood samples and biopsy of abdominal paroie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Being tested
- blood samples, biopsy of abdominal paroie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
3 citrated tubes and 3 EDTA tubes
biopsy of abdominal paroieOther
a muscle biopsy will be performed on the incision area
| Study group | Role | What they receive |
|---|---|---|
| patients without liver disease, | Other | taking blood samples and biopsy of muscular wall Receives: Other: blood samples; Other: biopsy of abdominal paroie |
| patient with chronic liver disease without cirrhosis, | Other | taking blood samples and biopsy of muscular wall Receives: Other: blood samples; Other: biopsy of abdominal paroie |
| patients with compensated cirrhosis, | Other | taking blood samples and biopsy of muscular wall Receives: Other: blood samples; Other: biopsy of abdominal paroie |
| patient with severe cirrhosis | Other | taking blood samples and biopsy of muscular wall Receives: Other: blood samples; Other: biopsy of abdominal paroie |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after the of inclusion
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 αSMA count
Measured: 1 month after the of inclusion
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
Measured: 1 month after the of inclusion
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
Measured: 1 month after the of inclusion
Secondary outcomes (2)
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
Measured: 1 month after the of inclusion
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
Measured: 1 month after the of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start15 Feb 2021 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Having a Scheduled Abdominal Surgery ProcedureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758793
- Sponsor's protocol ID
- APHP201215
- Acronym
- UNIVERSE
- Status last verified
- Dec 2020
- First submitted
- 7 Jan 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscles in Liver Diseases
- ClinicalTrials.gov ID
- NCT04758793
- Acronym / sponsor ID
- UNIVERSE / APHP201215
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients without liver disease, | Other | Other: blood samples, Other: biopsy of abdominal paroietaking blood samples and biopsy of muscular wall |
| patient with chronic liver disease without cirrhosis, | Other | Other: blood samples, Other: biopsy of abdominal paroietaking blood samples and biopsy of muscular wall |
| patients with compensated cirrhosis, | Other | Other: blood samples, Other: biopsy of abdominal paroietaking blood samples and biopsy of muscular wall |
| patient with severe cirrhosis | Other | Other: blood samples, Other: biopsy of abdominal paroietaking blood samples and biopsy of muscular wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples3 citrated tubes and 3 EDTA tubes | Other | patient with chronic liver disease without cirrhosis,, patient with severe cirrhosis, patients with compensated cirrhosis,, patients without liver disease, |
| biopsy of abdominal paroiea muscle biopsy will be performed on the incision area | Other | patient with chronic liver disease without cirrhosis,, patient with severe cirrhosis, patients with compensated cirrhosis,, patients without liver disease, |
Primary outcome
describe the muscle changes that occur during liver disease.
Time frame: 1 month after the of inclusion
Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers
describe the muscle changes that occur during liver disease.
Time frame: 1 month after the of inclusion
Assessment of the histology of the muscle removed during abdominal surgery, by evaluating the vascularity with measurements of CD31 count and αSMA count
describe the muscle changes that occur during liver disease.
Time frame: 1 month after the of inclusion
Assessment of the histology of the muscle removed during abdominal surgery by evaluating the muscle stem cells with measurements of Pax7, MyoD and Myogenin
describe the muscle changes that occur during liver disease.
Time frame: 1 month after the of inclusion
Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics
2 secondary outcomes
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
Time frame: 1 month after the of inclusion
Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs
Time frame: 1 month after the of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples and biopsy of abdominal paroie in people with Patients Having a Scheduled Abdominal Surgery Procedure, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pierre Emmanuel Rautou (140875283 ext. 33, pierre.emmanuel.rautou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
describe the muscle changes that occur during liver disease. (time frame: 1 month after the of inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.