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Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

I

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Withdrawn

Conditions

Liver Carcinoma

Treatments

Behavioral: HCC under treatment with radioablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01744639
GAS 720-12/13-1

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

HCC under treatment with radioablation
Experimental group
Description:
Assessment 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.
Treatment:
Behavioral: HCC under treatment with radioablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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