Ultrasound-enhanced fine-needle aspiration biopsy improves yield of solid benign parotid gland tumor tissue: a pilot study.

OBJECTIVES

Fine-needle aspiration biopsy (FNAB) and core-needle biopsy (CNB) are common methods to evaluate the pathology of an abnormal tissue mass. However, both methods have their limitations, e.g., FNAB samples often remain inadequate, and CNB is more invasive. A novel device, ultrasound-enhanced fine-needle aspiration biopsy (USeFNAB), can collect samples with greater cellular content quantitatively without compromising tissue quality. The purpose of this prospective study was to evaluate USeFNAB for the first time in humans in vivo.

MATERIALS AND

METHODS

This is a pilot study without any deviation from the contemporary management of the salivary gland tumor. Ten adult patients with a solid benign parotid gland tumor diagnosed by FNAB or CNB. Before parotidectomy, the tumors were sampled under ultrasound guidance with three different needle sampling techniques: USeFNAB, FNAB, and CNB. The influence of USeFNAB on the quantity and quality of the samples was investigated and compared with FNAB and CNB.

RESULTS

The quality of the cytological slides and histological tissue samples was similar in all samples obtained by USeFNAB, FNAB, and CNB. With USeFNAB, the mass increased on average by 1.6 and 3.4 times and the histological sample area by 1.7 and 3.4 times, as compared to FNAB and CNB, respectively.

CONCLUSION

The results of this study demonstrated that USeFNAB seems to be a feasible and safe biopsy technique under in vivo conditions. In solid benign parotid gland tumors, USeFNAB increases sample yield as compared to conventional needle sampling methods, without affecting sample quality.

RELEVANCE STATEMENT: USeFNAB could improve the diagnostic accuracy of needle biopsies and facilitate ancillary techniques such as molecular diagnostic studies.

TRIAL REGISTRATION: Institutional permissions for the study were granted. The USeFNAB protocol went through risk analysis and mitigation for approval by the Finnish Medicine Agency (FIMEA) as an investigational device for research purposes (FIMEA/2023001788).

KEY POINTS: USeFNAB showed an improved sample yield in solid benign parotid gland tumors compared to FNAB and CNB, without affecting sample quality. USeFNAB seems to be a feasible and safe biopsy technique. USeFNAB is a promising tool for improving the diagnostic accuracy of needle biopsies.