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

NCT04466709 | Unknown

• 1 other identifier: 5226
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Sarcopenic Obesity; Cirrhosis, Liver

Keywords

sarcopenia; myosteatosis

Outcome Measures

Primary Outcomes (1)

• sarcopenia and mortality

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

  1 year

Secondary Outcomes (3)

• sarcopenic obesity/myosteatosis and mortality

  1 year

• sarcopenia, sarcopenic obesity/myosteatosis and complication of liver disease

  1 year

• Methods Concordance

  1 year

Interventions

none intervention type OTHER

This is an observational study, no intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Active list for liver transplantation (LT) (patients at evaluation for LT will beenrolled);
• hepatocellular carcinoma HCC;
• previous LT or listing for multivisceral or living-related LT;
• concomitant neuromuscular disease;
• Patients with acute or subacute liver failure without underlying cirrhosis;
• Evidence of current malignancy except for non-melanocytic skin cancer;
• 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);
• HIV-positive patients;
• 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;

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Gastroenterology Department, Sapienza University of Rome

Rome, 00100, Italy

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Study Officials

• Manuela Merli, Professor

  Sapeinza University of Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Merli, Professor

CONTACT

0649972002; manuela.merli@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: July 10, 2019
• Primary Completion: July 5, 2020
• Study Completion: January 1, 2022
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)