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The Relationship Betweensarcopenia And Myosteatosis With The Natural History Of Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT04466709
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Manuela Merli, University of Roma La Sapienza

Brief Summary:

Malnutrition is a common figure associated with liver cirrhosis. The main component of malnutrition in liver cirrhosis is represented by sarcopenia, a condition of a progressive and generalized loss of muscle mass and strength. Many studies have reported that sarcopenia is an independent predictor of morbidity and mortality in cirrhotic patients.

Moreover, cirrhotic patients may develop simultaneous loss of skeletal muscle and gain of adipose tissue, culminating in a condition of "sarcopenic obesity".

As highlighted by a recent systematic review and meta-analysis [Van Vgut 2017] all the studies on the impact of sarcopenia/sarcopenic obesity and myosteatosis in cirrhotic patients are retrospective studies, mostly involving non-consecutive patients on the list for liver transplantation. Moreover, most of the studies were produced by non-European centers (Canadians,Americans, and Japanese) that published more papers on the same patient series. All these factors have led to a possible selection bias.

Furthermore, the methods used to evaluate sarcopenia and myosteatosis were not homogeneous (the entire muscle area, or area of the psoas or psoas diameter) as well as the cut-offs used.

For these reasons, we propose a multicentric observational prospective study aimed at analyzing the impact of sarcopenia, sarcopenic obesity and myosteatosis in cirrhotic patients not listed for liver transplantation.

Primary endpoint:

- Evaluation of the impact of sarcopenia on the mortality of cirrhotic patients not on the waiting list for liver transplantation.

Secondary end-point:

  • Evaluation of the impact of sarcopenic obesity and myosteatosis on the mortality of cirrhotic patients not on the waiting list for liver transplantation.
  • Evaluation of the impact of sarcopenia/sarcopenic obesity and myosteatosis on the development of complications (hepatic encephalopathy, bacterial infections, ascites, GI bleeding) in cirrhotic patients not on the waiting list for liver transplantation.
  • Evaluation of the impact of sarcopenia/sarcopenic obesity and myosteatosis on the number of admissions and the days of hospitalization for such complications.
  • Evaluation of the subcutaneous fat impact on mortality and morbidity of cirrhotic patients not on the waiting list for liver transplantation.
  • Concordance analysis of the various methods used (different cut-off/area psoas vs. area of all muscles) for the diagnosis of sarcopenia through the analysis of CT scan.

Condition or disease Intervention/treatment
Sarcopenia Sarcopenic Obesity Cirrhosis, Liver Other: none intervention type

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Study Type : Observational
Estimated Enrollment : 374 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Betweensarcopenia And Myosteatosis With The Natural History Of Liver Cirrhosis
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : July 5, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis


Intervention Details:
  • Other: none intervention type
    This is an observational study, no intervention


Primary Outcome Measures :
  1. sarcopenia and mortality [ Time Frame: 1 year ]
    Evaluation of the impact of sarcopenia on the mortality of cirrhotic patients not on the waiting list for liver transplantation.


Secondary Outcome Measures :
  1. sarcopenic obesity/myosteatosis and mortality [ Time Frame: 1 year ]
    Evaluation of the impact of sarcopenic obesity and myosteatosis on the mortality of cirrhotic patients not on the waiting list for liver transplantation.

  2. sarcopenia, sarcopenic obesity/myosteatosis and complication of liver disease [ Time Frame: 1 year ]
    Evaluation of the impact of sarcopenia/sarcopenic obesity and myosteatosis on the development of complications (hepatic encephalopathy, bacterial infections, ascites, GI bleeding) in cirrhotic patients not on the waiting list for livertransplantation.

  3. Methods Concordance [ Time Frame: 1 year ]
    Concordance analysis of the various methods used (different cut-off/area psoas vs. area of all muscles) for the diagnosis of sarcopenia through the analysis of CT scan.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The sample size has been planned using results from an analogous retrospective study, where the HR for sarcopenia was estimated as 2.2, the 1-y event rate was 30%, and 40% of the sample had sarcopenia. We therefore conservatively assume a sHR equal to 2, 20% 1-y cause-specific event rate, 40% baseline sarcopenia. According to these data, a total of 68 cause-specific events are needed to guarantee the power of at least 80% with a type I error rate of 5%. Since we assume a 20% event rate, with a follow-up of 1y as planned 340 patients (68/0.2) will be enrolled. Considering a possible 10% drop-out, a total of 374 patients will be enrolled in the study.
Criteria

Inclusion Criteria:

all patients with liver cirrhosis (age 40 - 75 years) undergoing abdominal CT-scan including the third lumbar L3 vertebrae for the clinical indication (surveillance of focal liver lesions, vascular evaluation, pre-transplant evaluation, pre-TIPS evaluation.) will be considered for the enrollment.

Exclusion Criteria:

  1. Active list for liver transplantation (LT) (patients at evaluation for LT will beenrolled);
  2. hepatocellular carcinoma HCC;
  3. previous LT or listing for multivisceral or living-related LT;
  4. concomitant neuromuscular disease;
  5. Patients with acute or subacute liver failure without underlying cirrhosis;
  6. Evidence of current malignancy except for non-melanocytic skin cancer;
  7. Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (NYHA III-IV); severe chronic pulmonary disease (GOLD > III), severe neurological and psychiatric disorders);
  8. HIV-positive patients;
  9. Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466709


Contacts
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Contact: Manuela Merli, Professor 0649972002 manuela.merli@uniroma1.it

Locations
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Italy
Gastroenterology Department, Sapienza University of Rome Recruiting
Rome, Italy, 00100
Contact: Manuela Merli    +39 06 49972002    manuela.merli@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Manuela Merli, Professor Sapeinza University of Roma
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Responsible Party: Manuela Merli, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04466709    
Other Study ID Numbers: 5226
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuela Merli, University of Roma La Sapienza:
sarcopenia
myosteatosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Sarcopenia
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms