About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
US-GUIDED PERCUTANEOUS LUNG NEEDLE BIOPSY
Diagnostic testThe 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
Diagnostic testThe 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 .
Treatment groups
Trial outcomes
Primary outcomes
Rate of diagnostic samples vs rate of non diagnostic samples assessed by the histological reports, detecting the ones positive for malignant neoplasm or specific benign process out of the totality of procedures for both US-guided and CT-guided biopsy
For diagnostic sampling is meant the ability to diagnose a malignant neoplasm or a specific benign process (such as benignant neoplasia, granulomatous inflammation). For nondiagnostic sample is meant the finding of a non-specific benign process or that the sample is not adequate/sufficient. For benign non-specific is meant a histological diagnosis suggesting a benign process without any evidence of malignancy but that does not give the specific information to achieve a definitive diagnosis. In any case that does not include a diagnostic confirmation of a non-specific benign lesion by a surgical approach, TTNA will be considered a true negative only after a follow-up documenting a downsizing of at least 20% in the major axial diameter or a stability in sizing for at least one year from the lesion itself.
Secondary outcomes
Rate of complications that can be occur during the procedures assessed by physiological parameter, VAS scale, radiography
The data about number and the type of complications during and after the procedure will be collected to calculate the rate of complications for both US-guided and CT-guided biopsies. The investigator will evaluate the pain by VAS scale which goes from 0 (no pain) to 10 (worst pain possible). The physiological parameters will be checked during the procedure and within three hours after the procedure. The patient will undergo radiography to check one hour after the procedure.
Amount of Ionizing radiation to which the patient is exposed calculated in mGy
During each procedure of CT-guided biopsy the investigators will obtain information about the amount of ionizing radiation to which the patient is exposed and this will be reported in mGy.
Comfort of the patient during the procedure assessed by Visual Analog Pain Scale(VAS scale)
The patient will be asked about the discomfort related to the procedure by VAS scale, which goes from 0 (extreme discomfort-absence of comfort) to 100 (extreme comfort-absence of discomfort)
Duration of the procedure in seconds
The duration of each procedure (from the time of the local anesthesia for the time of the extraction of the last biopsy)will be calculated and reported in seconds
Sponsors and contacts
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