Performance of a new histology needle for EUS-guided fine needle biopsy: A retrospective multicenter study.

OBJECTIVE

Procurement of tissue core biopsy may overcome some of the limitations of EUS-FNA. We aimed at assessing the safety, core procurement yield and diagnostic accuracy of two novel available histology needles.

METHODS

Data from consecutive patients with solid lesions who underwent EUS-FNB using the 25G-22G SharkCore™ needles were retrieved from 4 tertiary-care centers database.

RESULTS

146 patients (mean age 64 ± 12 years; M/F, 76/68) with 156 lesions (114 pancreatic) were identified. In 83 cases the 22G needle was used. 3.6 ± 1.2 passes per lesion were performed, without any major complications. A core biopsy was procured in 89.1% of cases. Considering malignant vs. non-malignant disease, the sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, and diagnostic accuracy were 90.2% (95% CI, 83.7-94.3), 100% (95% CI, 87.2-100), 0.099 (95% CI, 0.058-0.170), 60.4 (95% CI, 3.86-947.4), and 92.3% (95% CI, 88.1-96.5). Procurement yield was significantly higher for the 22G (95.2% vs. 82.2%, p = 0.011), despite the fact that more needle passes were performed with the 25G needle (3.8 ± 1.3 vs. 3.4 ± 1.0, p = 0.028).

CONCLUSIONS

EUS-FNB using the 25G-22G SharkCore™ needles is able to reach a very good procurement yield and diagnostic accuracy. The 22G-size needle showed superior core procurement and diagnostic capabilities. Large prospective studies are warranted to further evaluate the use of these types of needles.