Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions

Abstract

Background: To overcome limitations of cytology, biopsy needles have been developed to procure histologic samples during EUS. Objective: To compare 22-gauge (G) FNA and 22G biopsy needles (FNB) for EUS-guided sampling of solid pancreatic masses. Design: Randomized trial. Setting: Tertiary-care medical center. Patients: This study involved 56 patients with solid pancreatic masses. Intervention: Sampling of pancreatic masses by using 22G FNA or 22G FNB devices. Main Outcome Measurements: Compare the median number of passes required to establish the diagnosis, diagnostic sufficiency, technical performance, complication rates, procurement of the histologic core, and quality of the histologic specimen. Results: A total of 28 patients were randomized to the FNA group and 28 to the FNB group. There was no significant difference in median number of passes required to establish the diagnosis (1 [interquartile range 1-2.5] vs 1 [interquartile range 1-1]; P = .21), rates of diagnostic sufficiency (100% vs 89.3%; P = .24), technical failure (0 vs 3.6%; P = 1.0), or complications (3.6% for both) between FNA and FNB needles, respectively. Patients in whom diagnosis was established in passes 1, 2, and 3 were 64.3% versus 67.9%, 10.7% versus 17.9%, and 25% versus 3.6%, respectively, for FNA and FNB cohorts. There was no significant difference in procurement of the histologic core (100% vs 83.3%; P = .26) or the presence of diagnostic histologic specimens (66.7% vs 80%; P = .66) between FNA and FNB cohorts, respectively. Limitations: Only pancreatic masses were evaluated. Conclusion: Diagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles are comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types. (Clinical trial registration number: AQ:NCT01394159.) (Gastrointest Endosc 2012;76:321-7.)

Novel diagnostic and therapeutic modalities using endoscopic ultrasound in pancreatic disease

“…55 To overcome the challenges presented by the TCB needle, new 19 G and 22 G fine needle biopsy (FNB) needles (EchoTip ProCore; Cook Medical, Bloomington, IN, USA) were developed, featuring a reverse bevel to better obtain core tissue. 45 Bang et al 47 revealed similar performance of the 22 G EUS-FNB to EUS-FNA in a prospective cohort study of 56 patients with SPL, including number of needle passes, diagnostic yield, technical success, or complications. EUS-FNB yield of core tissue was not significantly different than EUS-FNA (83.3% vs 100%; P = 0.26).…”

“…6,11,45 It has since become standard of care to obtain EUS-FNA of SPL based on its cytological diagnostic sensitivity exceeding 80% in cases without underlying chronic pancreatitis. 3,6,11,46,47 Recently, a meta-analysis of 33 studies by Hewitt et al 48 revealed a sensitivity of 85% (95% CI = 0.84-0.86). Beyond the reliability of EUS-FNA, it also remains a safe procedure, with multiple studies demonstrating a complication rate less than 3%.…”

“…6,45,46,50 Additionally, a core tissue sample is often vital to the diagnosis of well-differentiated pancreatic adenocarcinomas and lymphomas, as their tissue morphology is necessary for precise histological evaluation. 45,47,[50][51][52] These limits led to the development of the Tru-Cut biopsy needle (TCB) compatible with EUS (Quick-Core; Wilson-Cook Medical Inc., Winston-Salem, NC, USA) (Fig. 3).…”

“…EUS-FNB yield of core tissue was not significantly different than EUS-FNA (83.3% vs 100%; P = 0.26). 47 A 2015 study by Berzosa et al 56 compared the 22 G EUS-FNB needle with nowstandard 25 G EUS-FNA in 61 SPL. EUS-FNB and EUS-FNA were equivocal in obtaining adequate specimens (73.8% vs 81.9%; P = 0.37) and diagnostic yield (68.9% vs 75.4%, respectively), but FNA required a mean of 3.5 needles passes compared with 1.7 for FNB.…”

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“…More recently, a new generation of core biopsy needles have been introduced (Echotip Procore TM , Cook Medical, Winston-Salem, NC). Multiple prospective cohort studies have suggested a significant improvement in diagnostic yield with EUS-FNB, while one RCT and some retrospective series have shown varying results [19,22,23]. To date, there is limited published data comparing EUS-FNA and EUS-FNB with regard to diagnostic yield in pancreatic and non-pancreatic Background and study aims: Techniques to optimize endoscopic ultrasound-guided tissue acquisition (EUS-TA) in a variety of lesion types have not yet been established.…”