Comparison of 22G Standard and Franseen Needles in Endoscopic Ultrasound-Guided Tissue Acquisition for Diagnosing Solid Pancreatic Lesions: A Multicenter Randomized Controlled Trial

Abstract

Background and Aims

This large multicenter randomized controlled trial compared the diagnostic yields of 22G standard and 22G Franseen needles for endoscopic ultrasound-guided tissue acquisition (EUS-TA) of solid pancreatic lesions.

Methods

Consecutive patients with solid pancreatic lesions were prospectively randomized to EUS-TA using standard or Franseen needles. Samples obtained with the first needle pass, and with second and subsequent passes, were evaluated separately. The primary endpoint was the rate of accuracy for diagnosis of malignancy. Other endpoints included technical success rate, sample cellularity, adverse events, diagnostic accuracy in patient subgroups, and the diagnostic accuracy and numbers of second and subsequent needle passes.

Results

A total of 523 patients were randomized to EUS-TA using standard 22G needles (n=260) or 22G Franseen needles (n=263). The technical success rate in each group was 99.6%, with similar adverse event rates in the standard (1.5%) and Franseen (0.8%) needle groups. First-pass EUS-TA using the Franseen needle resulted in significantly greater diagnostic accuracy (84.0% vs. 71.2%; P<0.001) and sensitivity (82.4% vs. 66.7%; P<0.001) than first-pass EUS-TA using a standard needle, and also resulted in superior diagnostic accuracy in patients requiring immunostaining. Second and subsequent EUS-TA using Franseen needles showed significantly greater accuracy (94.7% vs. 90.0%; P=0.049) and sensitivity (94.0% vs.88.6%; P=0.047), and required fewer needle passes (1.81 vs. 2.03, P=0.008), than using standard needles.

Conclusions

EUS-TA with the Franseen needle is superior to EUS-TA with a standard needle with respect to diagnostic accuracy per pass, particularly in patients who require immunostaining, and number of passes when using macroscopic on-site evaluation. (Japan Registry of Clinical Trials; jRCTs052180062).