Randomized Trial Comparing the Franseen and Fork-tip Needles for EUS-guided Fine-needle Biopsy Sampling of Solid pancreatic Mass Lesions

Background And Aims: Recently, a 3-plane symmetric needle with Franseen geometry and a Fork-tip biopsy needle have been developed for histologic tissue procurement. We compared 22-gauge Franseen and 22-gauge Fork-tip needles in patients undergoing EUS-guided sampling of pancreatic masses.

Methods: Fifty patients underwent sampling using both 22-gauge Franseen and 22-gauge Fork-tip needles, with randomization of needle order. Two dedicated passes were performed using both needles for cell block. Subsequent passes were performed for rapid onsite evaluation (ROSE) using both needles alternately until diagnosis was established. The main outcome was to evaluate for histologic core tissue by comparing area of total tissue, tumor, desmoplastic fibrosis, and rate of retained tissue architecture between cohorts. Other outcomes were rates of diagnostic cell block and diagnostic adequacy at ROSE.

Results: Final diagnosis was pancreatic cancer in 44 patients, neuroendocrine tumor in 2, lymphoma in 1, and chronic pancreatitis in 3. There was no significant difference in area of total tissue (median 6.1 [interquartie range {IQR}, 3.5-10.5] vs 8.2 mm [IQR, 4.0-13.0], P = .50), tumor (median .9 [IQR .3-2.8] vs 1.0 mm [IQR .4-2.7], P = .33), desmoplastic fibrosis (median 4.3 [IQR, 2.0-6.7] vs 5.2 mm [IQR, 1.7-6.1], P = .71), retained architecture (100% vs 83%, P = .25), diagnostic cell block (96.0% vs 92.0%, P = .32), and diagnostic adequacy at ROSE (94.0% vs 98.0%, P = .32) between Franseen and Fork-tip needles, respectively.

Conclusions: There was no significant difference between Franseen and Fork-tip needles in yielding histologic tissue. Given their ability to yield diagnostic cell block in greater than 90% of patients, the new-generation fine-needle biopsy needles may obviate the need for ROSE. (Clinical trial registration number: NCT02910960.).