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

NCT ID: NCT03629444

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-10-01

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

Conditions

Sarcopenia in Liver Cirrhosis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

ct scan

all patients will be subjected to CT scan and anthroprometric measurments

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

marwa abdElRazek Ahmed sala.a makhlof

OTHER

Sponsor Role: lead

Responsible Party

marwa abdElRazek Ahmed sala.a makhlof

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

AssiutU2018

Identifier Type: -

Identifier Source: org_study_id