- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04895111
Endobronchial Ultrasound Strain Elastography in Sarcoidosis
Role of Endobronchial Ultrasound Strain Elastography (EBUS-SE) in Sarcoidosis: a Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the last decade, the possibility to sample under ultrasound guidance (endosonography) the intrathoracic lymph nodes through the airways (endobronchial ultrasound guided, EBUS-TBNA) or through the oesophagus (endoscopic ultrasound-guided fine needle aspiration, EUS-FNA/EUS-b-FNA) has revolutionized the diagnostic approach to sarcoidosis. Individual studies and meta-analyses performed in selected and unselected patient populations have shown that EBUS and EUS both have overall diagnostic accuracy exceeding 80%. In addition, endosonography provides useful information about lymph node density; indeed, the presence of inhomogeneity in the lymph node texture on B-mode during endosonography represents the most important factor favouring infection over sarcoidosis in patients with lymphadenopathy.
Although the diagnostic success rate of EBUS-TBNA in detecting granulomas in lymph nodes of patients with suspected sarcoidosis is very high, the procedure is not foolproof and tends to have a lower yield in stages II/III as compared to stage I disease. Clinical experience suggests that at least some of the false-negative EBUS-TBNA results in sarcoidosis patients may be caused by the presence of lymph nodes with extensive fibrosis. We aim to evaluate whether EBUS-SE may help identify fibrotic lymph nodes in sarcoidosis and if the outcome of EBUS-TBNA is different in lymph nodes for which EBUS-SE suggest high fibrotic content.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rocco Trisolini, MD
- Phone Number: +390630154204
- Email: rocco.trisolini@policlinicogemelli.it
Study Contact Backup
- Name: Fausto Leoncini, MD
- Email: fausto.leoncini@policlinicogemelli.it
Study Locations
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-
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Roma, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Contact:
- Fausto Leoncini, MD
- Phone Number: +390630154204
- Email: fausto.leoncini@policlinicogemelli.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older.
- ASA physical status I-III.
- Clinical/radiological (computed tomography) suspicion of sarcoidosis (Stages I to III)
Exclusion Criteria:
- Inability or unwillingness to consent.
- Severe bleeding disorders
- Contraindication for temporary interruption of the use of anticoagulant or antiplatelet therapy different from aspirin.
- Recent and/or uncontrolled cardiac disease, uncontrolled pulmonary hypertension.
- Compromised upper airway (eg, concomitant head and neck cancer or central airway stenosis for any reason).
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with suspected sarcoidosis
Consecutive patients with clinical and radiological (CT scan +/- PET) suspect of sarcoidosis
|
Measurement of tissue elasticity of hilar and mediastinal lymph nodes through strain elastography measured during an endonbronchial ultrasound examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• Diagnostic yield for the detection of granulomas on endosonography samples according to a mean value of the strain histogram <40 or ≥40
Time Frame: 15 days
|
The diagnostic yield for the detection of granulomas will be measured on a per lymph node basis (number of lymph nodes in which the pathological exam of endosonography samples identifies granulomas/number of lymph nodes submitted to endosonography)
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• Adequacy of endosonography samples according to a mean value of the strain histogram <40 or ≥40.
Time Frame: 15 days
|
The adequacy will be measured on a per lymph node basis (number of lymph nodes in which the pathological exam shows an adequate endosonography sample/number of lymph nodes submitted to endosonography) and is defined as the presence of a preponderance of lymphocytes at the pathological exam of the endosonography sample.
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15 days
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• Correlation between the strain elastography pattern measured with the mean value of the strain histogram and the following variables: age, sex, sarcoidosis stage (I vs II vs III), duration of sarcoidosis-related symptoms.
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4066
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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