Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study

Background: There are very few available data on the novel SharkCore? needles for EUS-FNB.

Aim: Comparison of the performance of the SharkCore? needles with the standard EUS-FNA needles for the diagnosis of solid upper GI masses.

Patients and methods: Single-center, retrospective cohort study in an academic tertiary referral hospital. Patients were matched 1:1 for the site of the lesion and the presence or absence of rapid on-site evaluation (ROSE).

Results: A total of 102 patients were included. There was no statistically significant difference in the mean number of passes (3.3?±?1.3 versus 3.4?±?1.5; p?=?.89). Similar results were observed at the subgroup with ROSE (4.3?±?1.3 versus 3.7?±?1.5; p?=?.26). More histological specimens were obtained with the SharkCore? needles compared to standard needles (59 versus 5%; p?<?.001). Diagnostic test characteristics were not significantly different (sensitivity: 91.5 versus 85.7; specificity: 100 versus 100%; accuracy: 92.2 versus 85.4% for SharkCore? versus standard needles, p?>?.05 in all cases). At multivariable analysis, there was no statistically significant difference in the mean number of passes in all patients (p?=?.23) and in the ROSE subgroup (p?=?.66). However, the SharkCore? needle obtained significantly more histological material than the standard needle (odds ratio 66; 95% confidence interval: 11.8, 375.8, p?<?.001). There was no significant difference in complication rates (p?=?.5).

Limitations: Retrospective study, single-center.

Conclusion: The SharkCore needles were similar to standard FNA needles in terms of the number of passes to reach diagnosis, but obtained significantly more histological specimen.