Study design
A historical cohort study was carried out,
with a retrospective collection of information,
for patients treated by the radiology department at Fundación Cardioinfantil,
between January 2013 and April 2017,
with diagnosis of CHC,
either by imaging or histology,
who received management with ARF.
Data collection was done by reviewing the clinical history,
laboratory results and the local database of diagnostic images.
Population
Patients treated by the Radiology department at Fundación Cardioinfantil,
between January 2013 and April 2017,
with diagnostic imaging or histology of CHC,
who received management with ARF.
Variables
Clinical variables
The sociodemographic variables included: sex,
age and vital status at the time of data collection.
The clinical variables were: etiology of cirrhosis: cryptogenic,
hepatitis C virus (HCV),
hepatitis B virus (HBV),
autoimmune,
NASH (non-alcoholic fatty liver disease),
alcoholism and hemochromatosis); diagnosis of cholangiocarcinoma; metastasis; portal thrombosis; Estimation of the severity of cirrhosis by the Child-Pugh scale calculated by the variables: total bilirubin: ≤ 2 mg / dL (+ 1 point),
2-3 mg / dL (+ 2 points) and> 3 mg / dL (+ 3 points); albumin:> 3.5 g / dL (+ 1 point),
2.8 - 3.5 g / dL (+ 2 points) and ≤2.8 g / dL (+ 3 points); INR: ≤1.7 (+ 1 point),
1.7-2-2 (+ 2 points) and> 2.2 (+3 points); ascites: absent (+1 point),
mild (+1 point) and moderate (+3 points); encephalopathy: no encephalopathy (+ 1 point),
grade 1-2 (+ 2 points) and grade 3-4 (+ 3 points).
Initially,
the Child-Pugh scale was designed to assess mortality risk,
but it is currently used to estimate severity and prognosis,
then it is considered well compensated disease (grade A: 5-6 points),
significant compromise (grade B: 7-9 points) and decompensated disease (grade C: 10-15 points),
with a one-year survival of 100,
80 and 45% respectively [1]; The MELD scale that stratifies the severity of end-stage renal disease and prioritizes patients who will be transplanted,
including the following variables: serum bilirubin (mg / dL),
INR,
creatinine (mg / dL),
dialysis at least 2 times in the last week and serum sodium (mEq / L).
Procedure variables
The variables related to the ARF procedure were: number of sessions due to injury,
limitations during the procedure,
complications and technique used.
Lesion Variables
The variables describing the lesions were: number of focal lesions,
liver segment where they were located and to avoid variability in the interpretation of liver lesions in patients with high risk of HCC,
the classification system and the LIRADS terminology were used to describe and describe classify the lesions,
only leading to ablation of the lesions categorized as probable (LIRADS 4) or definitive (LIRADS 5).
The LIRADS classification uses as variables: size,
arterial enhancement,
portal phase wash,
presence of pseudocapsule,
restriction and growth rate.
Evaluation of therapeutic efficacy
The follow-up was performed with a CT scan or with Magnetic Resonance Imaging with contrast medium,
for a better characterization and classification of the lesions.
The definition of response to treatment or progression of the disease was made using the mRECIST criteria (modified Response Evaluation Criteria in Solid Tumors),
which are defined as: complete response: disappearance of enhancement in intra-tumor arterial phase of all white lesions; partial response: the decrease of at least 30% in the sum of the diameters of the target lesions (enhancement in the arterial phase),
taking as reference the initial sum of the diameters of the target lesions; stable disease: any case that did not qualify for a partial response or progressive disease; and progression of the disease,
to a 20% increase in the sum of the diameters of the target lesions,
taking as reference the smallest sum of the diameters of target lesions recorded from the beginning of the treatment.
Inclusion criteria
- Patients who were taken for radiofrequency ablation between 2013 and 2017,
who met the following criteria:
- The BCLC (Barcelona Clinic Liver Cancer) management strategy include:
- Very early stage (Child-Pugh A,
single lesions less than 2 cm)
- Early stage (Child-Pugh A-B,
a single lesion smaller than 5 cm or less than 3 tumors smaller than 3 cm)
- Patients with Child-Pugh C who will benefit from the procedure.
- Liver focal lesions classified as LIRADS (Liver Imaging Reporting And Data System) 4 and 5.
- Patients not eligible for surgical resection.
Exclusion criteria
- Patients with missing data in the clinical history.
- Patients without follow-up with diagnostic images available at the FCI.
- < 18 years old.
Data collection techniques
Data collection was performed by reviewing clinical history,
laboratory results and a databes of diagnostic images from admission to the hospitial until the last imaging control.
The data was collected in an Excel file.
Processing and analysis techniques
Univariate analysis
The categorical variables were be analyzed through frequencies.
The Kolmogorov-Smirnov test was performed to evaluate the normality of continuous quantitative variables.
The parametric data were expressed with mean and standard deviation (SD),
and nonparametric data were described as median and interquartile range.
Bivariate analysis
The comparison of means between pre and post ablation values will be carried out with the Student's T test,
considering a significant p less than or equal to 0.005.
The data will be analyzed using the SPSS program [6] and the R program.