Evaluation of endoscopic ultrasound fine-needle aspiration versus fine-needle biopsy and impact of rapid on-site evaluation for pancreatic masses

Abstract

Background and study aims Endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) is traditionally considered a first-line strategy for diagnosing pancreatic lesions; however, given less than ideal accuracy rates, fine-needle biopsy (FNB) has been recently developed to yield histological tissue. The aim of this study was to compare diagnostic yield and safety between EUS-FNA and EUS-FNB in sampling of pancreatic masses.

Patients and methods This was a multicenter retrospective study to evaluate efficacy and safety of EUS-FNA and EUS-FNB for pancreatic lesions. Baseline characteristics including sensitivity, specificity, and accuracy, were evaluated. Rapid on-site evaluation (ROSE) diagnostic adequacy, cell-block accuracy, and adverse events were analyzed. Subgroup analyses comparing FNA versus FNB route of tissue acquisition and comparison between methods with or without ROSE were performed. Multivariable logistic regression was also performed.

Results A total of 574 patients (n = 194 FNA, n = 380 FNB) were included. Overall sensitivity, specificity, and accuracy of FNB versus FNA were similar [(89.09 % versus 85.62 %; P = 0.229), (98.04 % versus 96.88 %; P = 0.387), and 90.29 % versus 87.50 %; P = 0.307)]. Number of passes for ROSE adequacy and cell-block accuracy were comparable for FNA versus FNB [(3.06 ± 1.62 versus 3.04 ± 1.88; P = 0.11) and (3.08 ± 1.63 versus 3.35 ± 2.02; P = 0.137)]. FNA + ROSE was superior to FNA alone regarding sensitivity and accuracy [91.96 % versus 70.83 %; P < 0.001) and (91.80 % versus 80.28 %; P = 0.020)]. Sensitivity of FNB + ROSE and FNB alone were superior to FNA alone [(92.17 % versus 70.83 %; P < 0.001) and (87.44 % versus 70.83 %; P < 0.001)]. There was no difference in sensitivity though improved accuracy between FNA + ROSE versus FNB alone [(91.96 % versus 87.44 %; P = 0.193) and (91.80 % versus 80.72 %; P = 0.006)]. FNB + ROSE was more accurate than FNA + ROSE (93.13 % versus 91.80 %; P = 0.001). Multivariate analysis showed ROSE was a significant predictor of accuracy [OR 2.60 (95 % CI, 1.41–4.79)]. One adverse event occurred after FNB resulting in patient death.

Conclusion EUS-FNB allowed for more consistent cell-block evaluation as compared to EUS-FNA. EUS-FNA + ROSE was found to have a similar sensitivity to EUS-FNB alone suggesting a reduced need for ROSE as part of the standard algorithm of pancreatic sampling. While FNB alone produced similar diagnostic findings to EUS-FNA + ROSE, FNB + ROSE still was noted to increase diagnostic yield. This finding may favor a unique role for FNB + ROSE, suggesting it may be useful in cases when previous EUS-guided sampling may have been indeterminate.

• References

• 1 Hariharan D, Saied A, Kocher HM. Analysis of mortality rates for pancreatic cancer across the world. HPB (Oxford) 2008; 10: 58-62
• 2 Li H, Li W, Zhou QY. et al. Fine needle biopsy is superior to fine needle aspiration in endoscopic ultrasound guided sampling of pancreatic masses: A meta-analysis of randomized controlled trials. Medicine (Baltimore) 2018; 97: e0207
• 3 Tian L, Tang AL, Zhang L. et al. Evaluation of 22G fine-needle aspiration (FNA) versus fine-needle biopsy (FNB) for endoscopic ultrasound-guided sampling of pancreatic lesions: a prospective comparison study. Surg Endosc 2018; 32: 3533-3539
• 4 Lee YN, Moon JH, Kim HK. et al. Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study. Endoscopy 2014; 46: 1056-1062
• 5 Wang J, Zhao S, Chen Y. et al. Endoscopic ultrasound guided fine needle aspiration versus endoscopic ultrasound guided fine needle biopsy in sampling pancreatic masses: A meta-analysis. Medicine (Baltimore) 2017; 96: e7452
• 6 Moura DTH, de Moura EGH, Matuguma SE. et al. EUS-FNA versus ERCP for tissue diagnosis of suspect malignant biliary strictures: a prospective comparative study. Endosc Int Open 2018; 6: E769-E777
• 7 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
• 8 Guedes HG, Moura DTH, Duarte RB. et al. A comparison of the efficiency of 22G versus 25G needles in EUS-FNA for solid pancreatic mass assessment: A systematic review and meta-analysis. Clinics (Sao Paulo) 2018; 73: e261
• 9 De Moura DTH, Moura EGH, Bernardo WM. et al. Endoscopic retrograde cholangiopancreatography versus endoscopic ultrasound for tissue diagnosis of malignant biliary stricture: Systematic review and meta-analysis. Endosc Ultrasound 2018; 7: 10-19
• 10 Ribeiro A, Vazquez-Sequeiros E, Wiersema LM. et al. EUS-guided fine needle aspiration combined with flow cytometry and immunocytochemistry in the diagnosis of lymphoma. Gastrointest Endosc 2001; 53: 485-491
• 11 De Moura DTH, Rocha RSP, Jukemura J. et al. A rare non-oncological pancreatic mass: eosinophilic pancreatitis diagnosis through EUS-FNA. Endosc Int Open 2019; 7: E151-E154
• 12 Brunaldi VO, Coronel M, Chacon DA. et al. Subepithelial rectal gastrointestinal stromal tumor - the use of endoscopic ultrasound-guided fine needle aspiration to establish a definitive cytological diagnosis: a case report. J Med Case Rep 2017; 11: 59
• 13 De Moura DTH, Coronel M, Chacon DA. et al. Primary adenosquamous cell carcinoma of the pancreas: the use of endoscopic ultrasound guided - fine needle aspiration to establish a definitive cytologic diagnosis. Rev Gastroenterol Peru 2017; 37: 370-373
• 14 Cheng B, Zhang Y, Chen Q. et al. Analysis of fine-needle biopsy vs fine-needle aspiration in diagnosis of pancreatic and abdominal masses: a prospective, multicenter, randomized controlled trial. Clin Gastroenterol Hepatol 2018; 16: 1314-1321
• 15 Wani S, Mullady D, Early DS. et al. The clinical impact of immediate on-site cytopathology evaluation during endoscopic ultrasound-guided fine needle aspiration of pancreatic masses: a prospective multicenter randomized controlled trial. Am J Gastroenterol 2015; 110: 1429-1439
• 16 Levy MJ. Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and problems. Pancreatology 2007; 7: 163-166
• 17 Wittmann J, Kocjan G, Sgouros SN. et al. Endoscopic ultrasound-guided tissue sampling by combined fine needle aspiration and trucut needle biopsy: a prospective study. Cytopathology 2006; 17: 27-33
• 18 Yang Y, Li L, Qu C. et al. Endoscopic ultrasound-guided fine needle core biopsy for the diagnosis of pancreatic malignant lesions: a systematic review and meta-analysis. Sci Rep 2016; 6: 22978
• 19 Pepe MS. The statistical evaluation of medical tests for classification and prediction. Section 9.3. Oxford University Press; 2003
• 20 Campbell I. Chi-squared and Fisher-Irwin tests of two-by-two tables with small sample recommendations. Stat Med 2007; 26: 3661-3675
• 21 De Moura DTH, Coronel M, Ribeiro IB. et al. The importance of endoscopic ultrasound fine-needle aspiration in the diagnosis of solid pseudopapillary tumor of the pancreas: two case reports. J Med Case Rep 2018; 12: 107
• 22 Bang JY, Kirtane S, Krall K. et al. In memoriam: Fine-needle aspiration, birth: Fine-needle biopsy: The changing trend in endoscopic ultrasound-guided tissue acquisition. Dig Endosc 2019; 31: 197-202
• 23 Di Leo M, Crinò SF, Bernardoni L. et al. EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study. Dig Liver Dis 2019; 51: 1275-1280
• 24 Hucl T, Wee E, Anuradha S. et al. Feasibility and efficiency of a new 22G core needle: a prospective comparison study. Endoscopy 2013; 45: 792-798
• 25 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
• 26 Alatawi A, Beuvon F, Grabar S. et al. Comparison of 22G reverse-beveled versus standard needle for endoscopic ultrasound-guided sampling of solid pancreatic lesions. United European Gastroenterol J 2015; 3: 343-352
• 27 Strand DS, Jeffus SK, Sauer BG. et al. EUS-guided 22-gauge fine-needle aspiration versus core biopsy needle in the evaluation of solid pancreatic neoplasms. Diagn Cytopathol 2014; 42: 751-758
• 28 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
• 29 Rodrigues-Pinto E, Jalaj S, Grimm IS. et al. Impact of EUS-guided fine-needle biopsy sampling with a new core needle on the need for onsite cytopathologic assessment: a preliminary study. Gastrointest Endosc 2016; 84: 1040-1046
• 30 Arena M, Eusebi LH, Pellicano R. et al. Endoscopic ultrasound core needle for diagnosing of solid pancreatic lesions: is rapid on-site evaluation really necessary?. Minerva Med 2017; 108: 547-553
• 31 Crinò SF, Manfrin E, Scarpa A. et al. EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial. Dig Liver Dis 2019; 51: 901-906
• 32 Aadam AA, Wani S, Amick A. et al. A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy. Endosc Int Open 2016; 4: E497-E505
• 33 de Moura DTH, McCarty TR, Jirapinyo P. et al. Endoscopic ultrasound fine-needle aspiration versus fine-needle biopsy for lymph node diagnosis: a large multicenter comparative analysis. Clin Endosc 2019; [Epub ahead of print] PubMed PMID: 31794654
• 34 Elhanafi S, Mahmud N, Vergara N. et al. Comparison of endoscopic ultrasound tissue acquisition methods for genomic analysis of pancreatic cancer. J Gastroenterol Hepatol 2019; 34: 907-913
• 35 Eusebi LH, Thorburn D, Toumpanakis C. et al. Endoscopic ultrasound-guided fine-needle aspiration vs fine-needle biopsy for the diagnosis of pancreatic neuroendocrine tumors. Endosc Int Open 2019; 7: E1393-E1399
• 36 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