Comparison of the Diagnostic Accuracy: US-guided Percutaneous Lung Biopsies vs CT-guided in Peripheral Lung Lesions

Condition(s) studied

Investigational drug(s) / intervention(s)

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 .

Study 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

Primary outcome measure(s)

• 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 — 1 month
  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.

Trial sites (2)

More University Hospital of Ferrara trials in Italy