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Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions - 14/05/18

Doi : 10.1016/j.gie.2017.11.036 
Ji Young Bang, MD, MPH, Shantel Hebert-Magee, MD, Udayakumar Navaneethan, MD, Muhammad K. Hasan, MD, Robert Hawes, MD, Shyam Varadarajulu, MD
 Center for Interventional Endoscopy, Florida Hospital, Orlando, Florida, USA 

Reprint requests: Shyam Varadarajulu, MD, Medical Director, Center for Interventional Endoscopy, Florida Hospital, 601 East Rollins Street, Orlando, FL 32803.Medical DirectorCenter for Interventional EndoscopyFlorida Hospital601 East Rollins StreetOrlandoFL32803

Abstract

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 mm2 [IQR, 4.0-13.0], P = .50), tumor (median .9 [IQR .3-2.8] vs 1.0 mm2 [IQR .4-2.7], P = .33), desmoplastic fibrosis (median 4.3 [IQR, 2.0-6.7] vs 5.2 mm2 [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.)

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : EUS-FNB, FNB, ROSE


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 DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: R. Hawes, S. Varadarajulu: Consultant for Boston Scientific and Olympus America. All other authors disclosed no financial relationships relevant to this publication.
 If you would like to chat with an author of this article, you may contact Dr Varadarajulu at svaradarajulu@yahoo.com.


© 2018  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 87 - N° 6

P. 1432-1438 - giugno 2018 Ritorno al numero
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