SarcoidosisNCT04735302
Radiographic Characteristics of Mediastinal and Hilar Lymph Nodes in Sarcoidosis
An observational study of Sarcoidosis and Lymph Node Disease, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Lymph Node Disease
- What is being tested?
- Radiographic Feature
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2019to 22 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- The 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
Who cannot join
- The patients whose computerized thoracic tomography images at first admission were not available in the archives of our hospital were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department Of Chest Diseases, School Of medicine, Karadeniz Technical University
Trabzon, 61080
About this study
Official title: Diagnostic Value of Radiographic Characteristics of Mediastinal and Hilar Lymph Nodes in Sarcoidosis
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.
Read the detailed 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).
- Conditions
- Sarcoidosis, Lymph Node Disease
- Being tested
- Radiographic Feature
- Keywords
- sarcoidosis, lymh nodes, Thorax tomography
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic FeatureOther
Radiographic rewiev
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis, Nonsarcoidosis | Not described Receives: Other: Radiographic Feature | |
| Malign, benign | Not described Receives: Other: Radiographic Feature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of biopsy necessay
Diagnosis of sarcoidosis without lymph node biopsy by Thorax computed tomography
Measured: 11.012019-22.01.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start11 Feb 2019
- Primary completion1 Aug 2019
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Ayçiçek, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735302
- Sponsor's protocol ID
- 24237859-153
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Radiographic Characteristics of Mediastinal and Hilar Lymph Nodes in Sarcoidosis
- ClinicalTrials.gov ID
- NCT04735302
- Acronym / sponsor ID
- 24237859-153
- Conditions
- Sarcoidosis, Lymph Node Disease
- Keywords
- sarcoidosis, lymh nodes, Thorax tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis, Nonsarcoidosis | – | Other: Radiographic Feature |
| Malign, benign | – | Other: Radiographic Feature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- The 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
Key exclusion criteria (1 listed)
- The patients whose computerized thoracic tomography images at first admission were not available in the archives of our hospital were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiographic FeatureRadiographic rewiev | Other | Malign, benign, Sarcoidosis, Nonsarcoidosis |
Primary outcome
Assesment of biopsy necessay
Time frame: 11.012019-22.01.2021
Diagnosis of sarcoidosis without lymph node biopsy by Thorax computed tomography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis and Lymph Node Disease, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of biopsy necessay (time frame: 11.012019-22.01.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.