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Comparison of the Diagnostic Accuracy: US-guided Percutaneous Lung Biopsies vs CT-guided in Peripheral Lung Lesions
Sponsor: University Hospital of Ferrara
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,
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2024-03-08
Completion Date
2026-10-31
Last Updated
2024-12-06
Healthy Volunteers
No
Conditions
Interventions
US-GUIDED PERCUTANEOUS LUNG NEEDLE BIOPSY
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 .
CT-GUIDED PERCUTANEOUS LUNG NEEDLE BIOPSY
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)
UO Pneumologia AOSP-AUSL
Ferrara, Italy
UOC Pneumologia - Azienda ospedaliera A. Cardarelli
Naples, Italy