High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions

Abstract

Background: Current limitations of EUS-guided FNA include the need for multiple passes and on-site cytology assessment and lack of core specimen. Recently, a new 25-gauge core biopsy needle (PC25) was developed to overcome these limitations.

Objective: To determine the diagnostic yield of EUS-guided FNA aspiration biopsy (FNAB) when using the PC25 needle among patients with solid pancreatic lesions.

Design: Retrospective analysis.

Setting: Academic tertiary referral center.

Patients: Fifty consecutive patients with a solid pancreatic lesion underwent EUS-guided FNAB with PC25.

Interventions: EUS-guided FNAB with PC25.

Main outcome measurements: The primary outcome was the diagnostic yield in single and overall passes of EUS-guided FNAB when using the PC25 needle for pancreatic solid lesions.

Results: Cytologic analysis showed malignancy in 38 patients on the first pass, with a cumulative sensitivity of 83%, 91%, and 96% on passes 1, 2, and 3, respectively. Although visible core was reported in 46 patients (92%), histologic core was seen in 16 patients (32%). Histologic analysis showed malignancy in 29 patients on the first pass, with a cumulative sensitivity of 63% and 87% on pass 1 and passes 1 to 4, respectively. The sensitivity, specificity, and accuracy in combined cytologic and histologic results were 85%, 100%, and 86% for single pass and 96%, 100%, and 96% on multiple passes, respectively. No complications were seen.

Limitations: A retrospective study design at a single center using a single arm.

Conclusion: EUS-guided FNAB with the PC25 needle showed excellent single-pass and overall diagnostic yields. This needle appears to maintain a high cytologic yield, similar to standard 25-gauge FNA needles, while also providing some histologic core tissue.