Comparison of EUS-guided tissue acquisition using two different 19-gauge core biopsy needles: a multicenter, prospective, randomized, and blinded study

Background and study aims: The optimal core biopsy needle for endoscopic ultrasound (EUS) is unknown. The principle aim of this study is to compare outcomes of EUS-fine-needle biopsy (EUS-FNB) with a new 19-gauge EUS histology needle (ProCore, Cook Medical Inc., Winston-Salem, North Carolina, United States) to a conventional 19-gauge Tru-Cut biopsy (EUS-TCB) needle (19G, Quick-Core, Cook Medical Inc.).

Patients and methods: Patients referred for EUS who require possible histologic biopsy were prospectively randomized to EUS-FNB or EUS-TCB. With the initial needle, ≤ 3 biopsies were obtained until either technical failure or an adequate core was obtained. Patients with suspected inadequate biopsies were crossed over to the other needle and similarly ≤ 3 passes were obtained until adequate cores or technical failure occurred. Technical success, diagnostic histology, accuracy and complication rates were evaluated.

Results: Eighty-five patients (mean 58 years; 43 male) were randomized to FNB (n = 44) and TCB (n = 41) with seven patients excluded. Procedure indication, biopsy site, mass size, number of passes, puncture site, overall technical success and adverse events were similar between the two groups. FNB specimens had a higher prevalence of diagnostic histology (85 % vs. 57 %; P = 0.006), accuracy (88 % vs. 62 %; P = 0.02), mean total length (19.4 vs. 4.3 mm; P = 0.001), mean complete portal triads from liver biopsies (10.4 vs. 1.3; P = 0.0004) and required fewer crossover biopsies compared to those of TCB (2 % vs. 65 %; P = 0.0001). Overall technical success and complication rates were comparable.

Conclusion: EUS-FNB using a 19-gauge FNB needle is superior to 19-gauge EUS-TCB needle.

• References

• 1 Erickson RA. EUS-guided FNA. Gastrointest Endosc 2004; 60: 267-279
• 2 Wiersema MJ, Levy MJ, Harewood GC et al. Initial experience with EUS-guided Trucut needle biopsies of perigastric organs. Gastrointest Endosc 2002; 56: 275-278
• 3 Levy MJ, Jondal ML, Clain J et al. Preliminary experience with an EUS-guided trucut biopsy needle compared with EUS-guided FNA. Gastrointest Endosc 2003; 57: 101-106
• 4 Varadarajulu S, Fraig M, Schmulewitz N et al. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy 2004; 36: 397-401
• 5 Gines A, Wiersema MJ, Clain JE et al. Prospective study of a Trucut needle for performing EUS-guided biopsy with EUS-guided FNA rescue. Gastrointest Endosc 2005; 62: 597-601
• 6 Larghi A, Verna EC, Stavropoulos SN et al. EUS-guided trucut needle biopsies in patients with solid pancreatic masses: a prospective study. Gastrointest Endosc 2004; 59: 185-190
• 7 Itoi T, Itokawa F, Sofuni A et al. Puncture of solid pancreatic tumors guided by endoscopic ultrasonography: a pilot study series comparing Trucut and 19-gauge and 22-gauge aspiration needles. Endoscopy 2005; 37: 362-366
• 8 Fernandez-Esparrach G, Sendino O, Sole M et al. Endoscopic ultrasound-guided fine-needle aspiration and trucut biopsy in the diagnosis of gastric stromal tumors: a randomized crossover study. Endoscopy 2010; 42: 292-299
• 9 Wahnschaffe U, Ullrich R, Mayerle J et al. EUS-guided Trucut needle biopsies as first-line diagnostic method for patients with intestinal or extraintestinal mass lesions. Surg Endosc 2009; 23: 2351-2355
• 10 Thomas T, Kaye PV, Ragunath K et al. Efficacy, safety, and predictive factors for a positive yield of EUS-guided Trucut biopsy: a large tertiary referral center experience. Am J Gastroenterol 2009; 104: 584-591
• 11 Sakamoto H, Kitano M, Ko maki T et al. Prospective comparative study of the EUS guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle in patients with solid pancreatic masses. J Gastroenterol Hepatol 2009; 24: 384-390
• 12 Iglesias-Garcia J, Poley JW, Larghi A et al. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc 2011; 73: 1189-1196
• 13 Czaja AJ, Carpenter HA. Optimizing diagnosis from the medical liver biopsy. Clin Gastroenterol Hepatol 2007; 5: 898-907
• 14 Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med 2001; 344: 495-500
• 15 DeWitt J, Emerson RE, Sherman S et al. Endoscopic ultrasound-guided Trucut biopsy of gastrointestinal mesenchymal tumor. Surg Endosc 2011; 25: 2192-2202
• 16 Cotton PB, Eisen GM, Asbakken L et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
• 17 Saftoiu A, Vilmann P, Guldhammer SkovB et al. Endoscopic ultrasound (EUS)-guided Trucut biopsy adds significant information to EUS-guided fine-needle aspiration in selected patients: a prospective study. Scand J Gastroenterol 2007; 42: 117-125
• 18 Storch I, Jorda M, Thurer R et al. Advantage of EUS Trucut biopsy combined with fine-needle aspiration without immediate on-site cytopathologic examination. Gastrointest Endosc 2006; 64: 505-511
• 19 Shah SM, Ribeiro A, Levi J et al. EUS-guided fine needle aspiration with and without trucut biopsy of pancreatic masses. JOP 2008; 9: 422-430
• 20 Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc 2012; 76: 336-343