Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2021-03-15
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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ROSE group
Ultrasound-assisted percutaneous needle aspiration with rapid on-site evaluation
Rapid on-site evaluation
Rapid on site evaluation performed with an MGG quick stain (Bio-Optica, Milano, Italy).
US NAB group
Ultrasound-assisted percutaneous needle aspiration without rapid on-site evaluation
No interventions assigned to this group
Interventions
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Rapid on-site evaluation
Rapid on site evaluation performed with an MGG quick stain (Bio-Optica, Milano, Italy).
Eligibility Criteria
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Inclusion Criteria
* Presence of a suspected "superficial" metastasis at imaging studies (CT and/or PET)
* Indication to tissue sampling for diagnosis, staging and/or molecular profiling
* 18 years or older
* Provision of a written informed consent
Exclusion Criteria
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
* Use of antiplatelet (excluded aspirin) or anticoagulant drugs that cannot be discontinued
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Rocco Trisolini, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
Countries
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References
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Meena N, Bartter T. Ultrasound-guided Percutaneous Needle Aspiration by Pulmonologists: A Study of Factors With Impact on Procedural Yield and Complications. J Bronchology Interv Pulmonol. 2015 Jul;22(3):204-8. doi: 10.1097/LBR.0000000000000175.
Laursen CB, Naur TM, Bodtger U, Colella S, Naqibullah M, Minddal V, Konge L, Davidsen JR, Hansen NC, Graumann O, Clementsen PF. Ultrasound-guided Lung Biopsy in the Hands of Respiratory Physicians: Diagnostic Yield and Complications in 215 Consecutive Patients in 3 Centers. J Bronchology Interv Pulmonol. 2016 Jul;23(3):220-8. doi: 10.1097/LBR.0000000000000297.
Stigt JA, Oostdijk AH, Boers JE, van den Berg JW, Groen HJ. Percutaneous ultrasound-guided biopsies in the evaluation of thoracic tumours after PET-CT: a prospective diagnostic study. Respiration. 2012;83(1):45-52. doi: 10.1159/000330018. Epub 2011 Sep 16.
Other Identifiers
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3866
Identifier Type: -
Identifier Source: org_study_id
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