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

NCT06412289 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2024-12-06

No results posted yet for this 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,

Conditions

  • Peripheral Lung Lesions

Interventions

DIAGNOSTIC_TEST

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 .

DIAGNOSTIC_TEST

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 .

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Mario Tamburrini, Dr. · Arcispedale Sant'Anna

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2026-04-30
Completion
2026-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06412289 on ClinicalTrials.gov