An interventional study of Endoscopic ultrasound-guided fine-needle biopsy in Endoscopic Ultrasound and Fine-needle Aspiration, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Diagnostic
A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles.
Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 92 studies on the registry; 18 are open to participants now.
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The stylet will be removed and the needle will be pre-flushed with 1-2mL of saline. The lesion will then be punctured, and suction will be applied using a 10-mL pre-vacuum syringe. The sample collected will be pushed into a formalin vial with saline.
Procedure: Endoscopic ultrasound-guided fine-needle biopsy
After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm. The sample will be pushed into formalin using the stylet.
Procedure: Endoscopic ultrasound-guided fine-needle biopsy
Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)
Histologic yield
The rate of samples containing a tissue "core" (yes/no) for histological evaluation, defined as an intact piece of tissue of at least 550 μ
Time frame: 6 months
Tissue integrity
Tissue integrity will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: No cells/tissue 1. Cytological specimen (disaggregated cells representative of the target lesion not allowing for tissue architectural assessment) 2. Histologic microfragments (sample adequate for histological evaluation, namely an architecturally intact piece of tissue but without a "core") 3. Histologic "core" (defined as an architecturally intact piece of tissue measuring at least 550 μ)
Time frame: 6 months
Blood contamination
Blood contamination will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: Only blood 1. High blood contamination (\>50% of the surface) 2. Moderate blood contamination (25-50% of the surface) 3. Low blood contamination (\<25% of the surface)
Time frame: 6 months
Tumor fraction
The rate of samples containing an adequate tumor fraction ≥20 percent (i.e., ≥ 20 percent tumor cells in a background of benign nucleated cells).
Time frame: 6 months
Diagnostic accuracy
Diagnostic accuracy (defined as the ratio between the sum of true positive and true negative values divided by the number of lesions) will be calculated for each study arm
Time frame: 6 months
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Azienda Ospedaliera Universitaria Integrata Verona