Comparing the diagnostic adequacy of 25-Gauge fork-tip franseen reverse-bevel-type needles in EUS-guided tissue acquisition: A prospective randomized study with a retrospective control.

BACKGROUND AND OBJECTIVES

EUS-guided fine-needle biopsy (FNB) is an established technique for the acquisition of tissue to diagnose lesions of the gastrointestinal tract and surrounding organs. Recently, newer-generation FNB needles have been introduced, including a second-generation reverse-bevel and the third-generation fork-tip and Franseen needles. We aimed to determine if there was any difference between these needles in terms of cytopathological diagnostic yield, sample cellularity, or sample bloodiness.

METHODS

One hundred twenty-seven consecutive patients undergoing EUS-guided FNB of any solid lesion were randomized to use either a Franseen or fork-tip needle in a 1:1 ratio and were compared with 60 consecutive historical cases performed with reverse-bevel needles. Patient and procedure characteristics were recorded. Cases were reviewed by a blinded cytopathologist and graded based on cellularity and bloodiness. Overall diagnostic yield was calculated for each study arm.

RESULTS

One hundred seventy-six cases were eligible for analysis, including 109 pancreatic masses, 24 lymphoid lesions, 17 subepithelial lesions, and 26 other lesions. The final diagnosis was malignancy in 127 cases (72%). EUS-guided FNB was diagnostic in 141 cases (80%) overall and in 89% of cases where malignancy was the final diagnosis. There was no difference in diagnostic yield, sample cellularity, or sample bloodiness between the different needle types. There was no difference in adverse events between groups.

CONCLUSIONS

EUS-guided FNB performed using 25-gauge Franseen, fork-tip, and reverse-bevel needles resulted in similar diagnostic yield, sample cellularity, and sample bloodiness. Our results may not be extrapolated to larger-caliber needles of the same design.