Comparison of the Diagnostic Accuracy: US-guided Percutaneous Lung Biopsies vs CT-guided in Peripheral Lung Lesions
A Prospective, Randomized, Multicentric and Single-blinded Study on Accuracy and Safety of Ultrasound (US) Guided Percutaneous Needle Biopsy of Peripheral Lung Lesion Compared With Computed TomogrAphy (CT) Guided Needle Biopsy
University Hospital of Ferrara
236 participants
Mar 8, 2024
INTERVENTIONAL
Conditions
Summary
A non-sponsored prospective randomized single-blind national multicenter interventional study which aims to compare the diagnostic accuracy between US-guided percutaneous lung needle biopsies and CT-guided in peripheral lung lesions. Secondary endpoints are: * onset of number and type of complications during and after the procedure, within the first three hour; * exposition to ionizing radiation, in milligray(mGy); * patient comfort during the procedure; * duration of the procedure,
Eligibility
Inclusion Criteria2
- Willingness and ability to provide free and informed consent. Age older then 18 years old.
- Peripheric pulmonary lesions adherent to the thoracic wall in CT scans with indication to typing
Exclusion Criteria7
- Inability to provide free and informed consent, in the absence of an available legal guardian.
- Age younger then 18 years old.
- Terminal neoplastic diseases/ palliative care patients.
- Patients with one lung, anatomical of functional.
- Severe non-treatable blood clothing disfunctions.
- Severe organ failure (pulmonary, renal, hepatic or cardiac).
- Women in state of pregnancy.
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Interventions
The ultrasound investigation will be conducted using the ultrasound machine supplied to the Center involved in the trial and usually used in eTTNA procedures. Before the procedure, the vital signs of the patient will be noted and each operator will choose the most appropriate position for the sampling, based on the location of the lesion. The thoracic area to biopsy will then be defined and then there will be the setting of the sterile field. At this point, local anesthesia with a maximum of 20ml of 2% lidocaine will be administrated, marking down this time as the time of the beginning of the procedure. 18 Gauge needles will be used to collect the sample. For each patient, there will be collected a minimum number of one and a maximum number of three bioptic sampling .
The CT scan will be performed using the CT machinery equipped by the Center involved in the trial and usually used for the tTTNA procedures. Before the procedure, the vital signs of the patient will be noted and each operator will choose the most appropriate position for the sampling, based on the location of the lesion. The thoracic area to biopsy will then be defined and then there will be the setting of the sterile field. At this point, local anesthesia with a maximum of 20ml of 2% lidocaine will be administrated, marking down this time as the time of the beginning of the procedure. 18 Gauge needles will be used to collect the sample. For each patient, there will be collected a minimum number of one and a maximum number of three bioptic sampling .
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06412289