22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy
David Karsenti
1
Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Paris-Bercy, Charenton-le-Pont, France
,
Laurent Palazzo
2
Digestive Endoscopy Unit, Clinique du Trocadéro, Paris, France
,
Bastien Perrot
3
UMR1246_SPHERE Methods for Patient-Centered Outcomes and Health Research, Nantes University, France
,
Jacqueline Zago
4
Pathology Department, 29 rue du Colisée, Paris, France
,
Anne-Isabelle Lemaistre
5
Department of Pathology, Eurofins Biomnis, Lyon, France
,
Jérôme Cros
6
Beaujon Hospital, Pathology Department, Université de Paris, INSERM U1149, Clichy, France
,
Bertrand Napoléon
7
Digestive Endoscopy Unit, Hôpital Privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France
› Author AffiliationsTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03567863 Type of study: Multicenter randomized crossover trial
Background Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has been suggested for obtaining high quality tissue samples from pancreatic tumors. We performed a multicenter randomized crossover trial comparing EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle. The aims were to compare the quantity of targeted tissue (pancreas) and diagnostic accuracy for the two needles.
Methods 60 patients admitted for EUS-FNB in three endoscopy units were included. One pass was performed consecutively with each needle, in a randomized order. Histologic material was studied in a blinded manner with respect to the needle. The primary end point was mean cumulative length of tissue core biopsies per needle pass.
Results Final diagnosis was adenocarcinoma (n = 46; 77 %), neuroendocrine neoplasm (n = 11; 18 %), autoimmune pancreatitis (n = 2), and mass-forming chronic pancreatitis (n = 1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22G Acquire needle at 11.4 mm (95 % confidence interval [CI] 9.0 – 13.8] vs. 5.4 mm (95 %CI 3.8 – 7.0) for the 20G Procore needle (P < 0.001), as was the mean surface area (3.5 mm2 [95 %CI 2.7 – 4.3] vs. 1.8 mm2 [95 %CI 1.2 – 2.3]; P < 0.001). Diagnostic adequacy and accuracy were 100 % and 87 % with the 22G Acquire needle, and 82 % and 67 % with the 20G Procore needle (P = 0.001 and P = 0.02, respectively).
Conclusions EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.
1
Fritscher-Ravens A,
Topalidis T,
Bobrowski C.
et al. Endoscopic ultrasound-guided fine-needle aspiration in focal pancreatic lesions: a prospective intraindividual comparison of two needle assemblies. Endoscopy 2001; 33: 484-490
2
Savides TJ,
Donohue M,
Hunt G.
et al. EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement. Gastrointest Endosc 2007; 66: 277-282
3
Arewood GC,
Wiersema MJ.
Endosonography-guided fine needle aspiration biopsy in the evaluation of pancreatic masses. Am J Gastroenterol 2002; 97: 1386-1391
4
Eloubeidi MA,
Chen VK,
Eltoum IA.
et al. Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications. Am J Gastroenterol 2003; 98: 2663-2668
5
Song TJ,
Kim JH,
Lee SS.
et al. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol 2010; 105: 1739-1745
6
Bang JY,
Hebert-Magee S,
Trevino J.
et al. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc 2012; 76: 321-327
7
Vanbiervliet G,
Napoléon B,
Saint Paul MC.
et al. Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study. Endoscopy 2014; 46: 1063-1070
8
Bang JY,
Hawes R,
Varadarajulu S.
A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy 2016; 48: 339-349
9
Khan MA,
Grimm IS,
Ali B.
et al. A meta-analysis of endoscopic ultrasound-fine-needle aspiration compared to endoscopic ultrasound-fine-needle biopsy: diagnostic yield and the value of onsite cytopathological assessment. Endosc Int Open 2017; 5: E363-E375
12
Lang EK,
Macchia RJ,
Gayle B.
et al. CT-guided biopsy of indeterminate renal cystic masses (Bosniak 3 and 2F): accuracy and impact on clinical management. Eur Radiol 2002; 12: 2518-2524
14
Bang JY,
Hebert-Magee S,
Hasan MK.
et al. Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment. Dig Endosc 2017; 29: 338-346
15
Leung KiEL,
Lemaistre AI,
Fumex F.
et al. Macroscopic onsite evaluation using endoscopic ultrasound fine needle biopsy as an alternative to rapid onsite evaluation. Endosc Int Open 2019; 7: E189-E194
17
Bang JY,
Magee SH,
Ramesh J.
et al. Randomized trial comparing fanning with standard technique for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic mass lesions. Endoscopy 2013; 45: 445-450
18
Eloubeidi MA,
Tamhane A,
Varadarajulu S.
et al. Frequency of major complications after EUS-guided FNA of solid pancreatic masses: a prospective evaluation. Gastrointest Endosc 2006; 63: 622-629
20
Larghi A,
Verna EC,
Ricci R.
et al. EUS-guided fine-needle tissue acquisition by using a 19-gauge needle in a selected patient population: a prospective study. Gastrointest Endosc 2011; 74: 504-510
21
Iwashita T,
Yasuda I,
Mukai T.
et al. Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during EUS-guided FNA using a 19-gauge needle for solid lesions: a single-center prospective pilot study (MOSE study). Gastrointest Endosc 2015; 81: 177-185
22
Van Riet PA,
Larghi A,
Attili F.
et al. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointest Endosc 2019; 89: 329-339
23
Kandel P,
Tranesh G,
Nassar A.
et al. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc 2016; 84: 1034-1039
24
Jovani M,
Abidi WM,
Lee LS.
Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study. Scand J Gastroenterol 2017; 52: 784-787
25
Kurita A,
Yasukawa S,
Zen Y.
et al. Comparison of a 22-gauge Franseen-tip needle with a 20-gauge forward-bevel needle for the diagnosis of type 1 autoimmune pancreatitis: a prospective, randomized, controlled, multicenter study (COMPAS study). Gastrointest Endosc 2020; 91: 373-381.e2
27
Bang JY,
Hebert-Magee S,
Navaneethan U.
et al. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc 2018; 87: 1432-1438