Endobronchial Ultrasound Strain Elastography in Sarcoidosis

NCT ID: NCT04895111

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 701 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2024-03-31

Brief Summary

Strain elastography (SE) is an imaging method used for the measurement of relative tissue elasticity through qualitative (color pattern) or semi-quantitative methods (strain ratio or strain histogram). Very recently, the first pilot study has provided preliminary evidence that EBUS-SE elastography may help identify fibrotic lymph nodes in sarcoidosis and that sampling lymph nodes characterized by low strain elastography, that is "stiff" nodes, is associated with an increased risk of retrieving an inadequate sample (i.e. a sample which is not representative of the lymph node tissue). The investigators hypothesize that an EBUS-SE pattern indicative of lymph node stiffness will be associated with less granulomas and more fibrosis.

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.

Conditions

Sarcoidosis, Pulmonary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with suspected sarcoidosis

Consecutive patients with clinical and radiological (CT scan +/- PET) suspect of sarcoidosis

Endobronchial ultrasound strain elastography

Intervention Type: DIAGNOSTIC_TEST

Measurement of tissue elasticity of hilar and mediastinal lymph nodes through strain elastography measured during an endonbronchial ultrasound examination

Interventions

Endobronchial ultrasound strain elastography

Measurement of tissue elasticity of hilar and mediastinal lymph nodes through strain elastography measured during an endonbronchial ultrasound examination

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Rocco Trisolini, MD

Role: CONTACT

rocco.trisolini@policlinicogemelli.it

+390630154204

Fausto Leoncini, MD

Role: CONTACT

fausto.leoncini@policlinicogemelli.it

Facility Contacts

Fausto Leoncini, MD

Role: primary

fausto.leoncini@policlinicogemelli.it

+390630154204

Other Identifiers

4066

Identifier Type: -

Identifier Source: org_study_id