Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04735302 |
| Other study ID # |
24237859-153 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 11, 2019 |
| Est. completion date |
January 22, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Karadeniz Technical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: This study aimed to investigate the diagnostic value of thoracic computerized
tomography (CT) which is a noninvasive method making the diagnosis of sarcoidosis.
Material-Method: The data of 816 patients who received endobronchial ultrasonography (EBUS)
for mediastinal lymph node sampling and were subjected to other methods were retrospectively
analyzed. 192 patients (sarcoidosis: 62, non-sarcoidosis) were included in the study. The
thoracic CT findings of the patients were compared in terms of mediastinal lymph node and
pulmonary parenchymal involvement.
Description:
INTRODUCTION Sarcoidosisis a multisystemic granulomatous disease whose etiology is unknown.
The diagnosis of sarcoidosisis made by exclusion of other causes in addition to compatible
clinical, radiological and histopathological findings (1,2). Its most frequently encountered
form of stage-I sarcoidosis characterized by bilateral hilar lymphadenopathy (3). Symmetrical
hilar lymphadenopathy (LAP) is a significant characteristic that distinguishes sarcoidosis
from disease that may progress with mediastinal and hilar lymph nodes such as lymphoma,
fungal infection and tuberculosis (4,5). Unilateral hilar LAP is seen in only about 3-5%of
sarcoidosis cases (6).
Tissue biopsy is required to show granulomas that does not histopathologically contain
caseification necroses (7). However, in stage-I patients, sarcoidosis can be diagnosed
without tissue sampling after excluding other causes (8). The 2019 sarcoidosis guideline of
BTS (British Thoracic Society) also stated that, in patients with Lofgren syndrome (Bilateral
hilar lymphadenopathy, erythema nodosum, fever, arthritis) with a low probability of
alternative diagnosis, biopsy is required only when radiologically atypical findings are
revealed during follow up (9). However, in this case, the suspicion of whether or not the
correct decision is made remains a highly disturbing issue for both the physician and the
patient. Biopsy should be performed if the clinical condition is not typical, and other
causes could not be excluded. Bronchoscopy, which is frequently used for biopsy, is an
invasive procedure although its complication rate is low. In relation to bronchoscopy,
complications such as pneumothorax, hemorrhage and infection may be experienced
(10,11).Therefore, it is important to investigate if it is possible to prevent patients from
unnecessary invasive procedures. This study aimed to investigate the diagnostic value of
thoracic computerized tomography image characteristics in the diagnosis of sarcoidosis
without pathological sampling.
MATERIAL-METHOD The study was planned by retrospectively analyzing the data of patients who
received EBUS for sampling mediastinal lymph nodes and were subjected to other diagnostic
methods such as mediastinoscopy and thoracotomy in the case of non-diagnostic results of EBUS
at the Department of Pulmonology at the Faculty of Medicine at KTÜ between 1 January 2013 and
1 July 2019. The study was started after obtaining local ethics board approval, and only
included patients with definitive histopathological diagnosis. The patients whose
computerized thoracic tomography images at first admission were not available in the archives
of our hospital were excluded (Figure 1).
The computerized thoracic tomography images were examined in terms of characteristics as
mediastinal lymph node localization, size, density, homogeneity, necrosis, calcification and
hilar symmetry. Parenchymal lesions were compared in terms of nodule, ground-glass, reticular
opacity, consolidation and the distributions of these lesions. For computerized thoracic
tomography imaging, the Somatom (Siemens, Forchhim, Germany) device at our hospital was used.
For EBUS imaging and sampling, an Olympus EVIS EXERA II CV-180 device was used.
The assessment of lymph node localization was made based on the lymph node map by Wang (2R,
2L, 4R, 4L, etc.). Measurements of lymphadenopathy density were made by considering the
largest lymph node and by the Hounsfield Unit (HU) in a rectangular region determined in the
axial plane contacting the LAP borders from four corners in the tomography cross-section with
the lymphadenopathy showing the broadest area. The maximum, minimum and mean densities
measured at the marked region were recorded. The measurements were made by the same person in
all patients (Figure 2).
Statistical analysis Kolmogorov-Smirnov test was used to test the normal distribution of the
continuous variables. The data characterized by a normal distribution are expressed as
mean±standard deviation. Student's t-tests was used for the comparison of the data which had
a normal distribution. Mann-Whitney-U test was used for the comparison of the non-normally
distributed data. The discrete variables were compared using Chi-squared test. The parameters
that were potential predictors of sarcoidosis were analyzed using logistic regression
analysis. Multivariate logistic regression analysis was used as a stepwise backward LR method
from predictive factors with a significance of ≤0.05 in the univariate analysis. The
diagnostic accuracies of the parameters for identifying sarcoidosis were assessed using the
area under the receiver operating characteristic (ROC) (AUC). P <0.05 was considered to be
statistically significant. The data were analyzed using the SPSS statistical software
(version 13.01, serial number 9069728, SPSS Inc., Chicago).
