Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

NCT ID: NCT01744639

Last Updated: 2016-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Liver Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HCC under treatment with radioablation

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.

Group Type EXPERIMENTAL

HCC under treatment with radioablation

Intervention Type BEHAVIORAL

The evaluation will take place over a period of 30 days.

Interventions

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HCC under treatment with radioablation

The evaluation will take place over a period of 30 days.

Intervention Type BEHAVIORAL

Other Intervention Names

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Anthropometry Bioelectrical impedance

Eligibility Criteria

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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.


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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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ALDO TORRE DELGADILLO

Investigador Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aldo Torre Delgadillo, M.D. M.Sc

Role: PRINCIPAL_INVESTIGATOR

INCMNSZ

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, D.f., Mexico

Site Status

Countries

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Mexico

Other Identifiers

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GAS 720-12/13-1

Identifier Type: -

Identifier Source: org_study_id

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