Status:
COMPLETED
Prevalence and Malignant Involvement of Calcified Intrathoracic Lymph Nodes in Patients Undergoing Endosonography
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Lymphadenopathy
Lung Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination...
Detailed Description
The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination...
Eligibility Criteria
Inclusion
- Age \>18 years at the time of the procedure
- Known or suspected lung cancer or other intrathoracic malignancy based on imaging (CT and/or PET/CT)
- Endosonography (EBUS and/or EUS) indicated for intrathoracic lymph node assessment/sampling according to national and international guidelines: 1) enlarged (\> 1 cm on its short axis at CT) and/or PET positive lymph node; and/or 2) conditions at risk for occult mediastinal metastases, such as: i) central primary tumor; ii) primary tumor \> 3 cm; iii) PET negative primary tumor; iv) ipsilateral hilar metastasis (cN1 status).
Exclusion
- Inability or unwillingness to consent
- Compromised upper airway (i.e., concomitant head and neck cancer with upper airway obstruction; critical central airway obstruction from any cause)
- Contraindication for temporary interruption of the use of antiplatelet (excluded aspirin) or anticoagulant drugs
- American Society of Anesthesiologists grade 4
Key Trial Info
Start Date :
March 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT04743583
Start Date
March 20 2021
End Date
December 31 2022
Last Update
January 10 2023
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy