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Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

Not Applicable
Withdrawn
Conditions
Liver Carcinoma
Interventions
Behavioral: HCC under treatment with radioablation
Registration Number
NCT01744639
Lead Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Brief Summary

Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score and Critical Flicker Frequency.

Detailed Description

There will be a prospective, longitudinal, comparative. It included 20 patients diagnosed with hepatocellular carcinoma. As there are a finite number of active patients at the institute, and no studies with sample size well established, has seen a sample size of 20 patients.

The duration of individual monitoring shall be one month to three visits (baseline, week 2 and week 4 after receiving the first radiofrequency ablation). Each visit will be a nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF).

Anthropometric measures to be taken are weight, height and arm circumference average.

Bioelectrical impedance will be using a single frequency impedance meter (425 to -50 KHz, Range 0 to 10,000) Bioelectrical Body Composition Analyzer Quantium II RJL Systems. The team measured the subjects' impedance, resistance, reactance and phase angle by Lean Body program provided by the manufacturer.

Hepatic encephalopathy be evaluated by testing PHES and was measured CFF, also also be measured ammonium, tumor necrosis factor, IL-1, IL-6, IL-10, renin angiotensin aldosterone.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Patients with a diagnosis of hepatocellular carcinoma, treatment-naive and who are referred to the radiology department for radioablation as first therapy.
  • Outpatients.
  • Willingness to participate in the project.
Exclusion Criteria
  • Patients with hepato-renal diseases.
  • Patients diagnosed with hepatocellular carcinoma undergoing chemoembolization treatment, or who have received more than one session radioablation.
  • Patients with depression or psychiatric illnesses
  • Patients who do not agree to participate in the project.

Exclusion Criteria:

  • incomplete Applied Tests
  • disagreement of the person to perform any of the tests
  • monitoring Breach
  • Hospitalization or death after the first session radioablation.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
HCC under treatment with radioablationHCC under treatment with radioablationAssessment of nutritional status by anthropometry, bioelectrical impedance, blood sampling and application of psychometric hepatic encephalopathy score and critical flicker frequency, to assess the presence of hepatic encephalopathy.
Primary Outcome Measures
NameTimeMethod
Nutritional StatusParticipants will be evaluated for a month

Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculated mid-arm muscle circumference, fat mass, fat free mass total, intracellular and extracellular body water obtained by bioelectrical impedance analysis and individual vectors obtained by bioelectrical impedance vector analysis.

Secondary Outcome Measures
NameTimeMethod
Minimal hepatic encephalopathyParticipants will be assessed for one month

Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

🇲🇽

Mexico City, D.f., Mexico

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