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Assessment of Sarcopenia in Patients With Liver Cirrhosis and Its Prognostic Value in Liver Transplant Candidates

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ClinicalTrials.gov Identifier: NCT03629444
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
marwa abdElRazek Ahmed sala.a makhlof, Assiut University

Brief Summary:

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, shown to be prevalent in adults with cancer and common chronic comorbidities such as liver cirrhosis.

The EWGSOP identified a grading for Sarcopenia into pre-sarcopenia (decreased muscle mass with normal strength and physical performance), sarcopenia (decreased muscle mass with decreased strength or performance), severe Sarcopenia (decreased muscle mass, strength and performance) .

Sarcopenia has emerged as an independent predictor of poor prognosis in a variety of clinical conditions.Sarcopenia is clinically important because it can affectthe quality of life of patients with cirrhosis .

Skeletal muscle mass is not only a good indicator of nutrition in patients with cirrhosis, but also has recently been shown to be closely associated with survival prognosis and postoperative complications inHCC.

Combination of sarcopenia and the Model for End-stage Liver Disease (MELD) has been shown to be an excellent model for predicting prognosis in decompensated liver cirrhosis .

Most patients awaiting liver transplantation (LT) are more or less in a state of sarcopenia. Several studies have reported that sarcopenia was associated with worse prognosis.In addition, sarcopenia may be associated with a higher risk of post-transplant infection .

Assessment of sarcopenia in patients with liver cirrhosis:_ The European Working Group on Sarcopenia in Older People recommended that the definition of sarcopenia include not only low muscle mass but also low muscle function . They recommended cutoff values for muscle mass measurements (7.26 kg/m2 for men and 5.5 kg/m2 for women using dual X-ray absorptiometry, and 8.87 kg/m2 for men and 6.42 kg/m2 for women using bioimpedance analysis, handgrip strength (<30 kg for men and <20 kg for women), and usual gait speed (<0.8 m/s).

Aim of the study

  • To evaluate sarcopenia in different stages of liver cirrhosis by different diagnostic methods.
  • To identify the prognostic value of CT in the diagnosis of sarcopenia .
  • To identify effect of sarcopenia inliver transplant candidate.

Patients and methods:

Type of the study:the study is divided into two parts First part: observational descriptive cross sectional study. Second part: follow up of liver transplant candidate group (pre and post liver transplantation) Duration of study: expected duration of the study will be 1.5 years . The 1st part will include all patients admitted to the department for 1 year fulfill inclusion criteria .

2nd part will be 6 ms follow up after liver transplantation. Study population

  1. st part : Patients with liver cirrhosis will be evaluated for the presence of sarcopenia.
  2. nd part:

    • 13 cases of liver cirrhosis already done liver transplantation in AL Rajhiuneversitiy hospital(which data already recoreded) and any cirrhotic pts will be prerared for liver transplantion within six months.
    • Methods At the study entry, all candidates will be subjected to the following parameters (and 3 month after LT for liver transplant candidates only)
    • Clinical history
    • Clinical examination
    • Abdominal ultrasound
    • Laboratory investigation:

      • Liver function tests
      • Complete blood picture,
      • Kidney function tests,
      • Serum glucose, serum Na+ and K+
      • Hepatitis markers (HBsAg, HCV-Ab)
    • Calculate:

      = Child Pugh score (Pugh et al., 1973) and MELD (Wiesner et al., 2003) scores for assessment ofliver cirrhosis.

    • Anthropometric measurements:

      • Triceps skin fold thickness (TSF) .
      • Measure mid-arm circumference (MAC).
      • Body mass index
      • Hand grip to assess muscle strength
      • Gait speed to assess physical performance
    • Assessment of sarcopenia using CT scan:
    • Assessment of sarcopenia using ultrasound:
    • Assessment of sarcopenia using bioimpedance analysis

Condition or disease Intervention/treatment
Sarcopenia in Liver Cirrhosis Radiation: ct scan

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Assessment of Sarcopenia in Patients With Liver Cirrhosis and Its Prognostic Value in Liver Transplant Candidates
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: ct scan
    all patients will be subjected to CT scan and anthroprometric measurments


Primary Outcome Measures :
  1. grading of sarcopenia in liver cirrhosis . [ Time Frame: about one and half year ]
    all patients will done CT abdomen with lower limit 38 in female and 53 in male which mean sarcopenia all patients wiill be measure height in cm by stadiometer . all pateints will measure weight in kilograms by weight measuring device. all pateints will be calculated BMI which mean weight\(height)2. with normal range 18.5 to 24.9



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

First part: total coverage of all elligable patients admitted to the department for 1 year who expected 300 patients with liver cirrhosis (only 50 patients will be done CT abdomen due to financial obstacle).

- Second part:13 cases of liver cirrhosis already done liver transplantation in AL Rajhiuneversitiy hospital and any cirrhotic pts will be prerared for liver transplantion within six months.

Criteria

Inclusion Criteria:

  • Patients with liver cirrhosis.
  • Age: 18 - 65 years.

Exclusion Criteria:

Cirrhotic patients with:

  • Activecomorbid disease e.g. Diabetes mellitus, pulmonary, renal disease (especially .hepatorenal syndrome).
  • Malignancy
  • Receiving anabolic steroids

Responsible Party: marwa abdElRazek Ahmed sala.a makhlof, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03629444     History of Changes
Other Study ID Numbers: AssiutU2018
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Fibrosis
Sarcopenia
Pathologic Processes
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms