Macroscopic onsite evaluation using endoscopic ultrasound fine needle biopsy as an alternative to rapid onsite evaluation

Abstract

Background and aims This study aimed to evaluate the performance of Macroscopic On-site Evaluation (MOSE) using a novel endoscopic ultrasound (EUS) fine needle biopsy (FNB) needle (22-G Franseen-tip needle, Acquire, Boston Scientific Incorporated, Boston, Massachusetts, United States), and without using Rapid On-Site Evaluation (ROSE).

Method Between May 2016 and August 2016, all consecutive patients referred to our center for EUS tissue acquisition (TA) for solid lesions underwent EUS-FNB with the 22-G Franseen-tip needle unless contra-indicated. The operator performed MOSE. If no macroscopic core was visualized, a second pass was performed. The final diagnosis was defined as unequivocal histology from EUS-TA with compatible 18 months follow-up, surgical resection, or both. We retrospectively analyzed the performance of MOSE.

Results A total of 46 consecutive patients was included, and 54 solid lesions were biopsied. The endosonographer visualized core tissue in 93 % (50/54) of targets with a single pass, of which the pathologist confirmed histologic core fragments in 94 % (47/50). Four lesions required two passes, and the overall correlation between MOSE and histologic core fragments was 94 % (48/51). Diagnostic adequacy was 98 % (53/54) with one biliary target biopsied without significant material. The overall diagnostic accuracy was 94 %. Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 92 %, 100 %, 100 %, and 81 %, respectively. No adverse events were reported.

Conclusion Our study demonstrated that MOSE using the 22-G Franseen-tip needle could limit needle passes by accurately estimating histologic core fragments. It also demonstrated that high diagnostic adequacy and accuracy of > 90 % could be achieved without ROSE.

• References

• 1 Dumonceau JM, Deprez PH, Jenssen C. et al. Indications, results and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – updated January 2017. Endoscopy 2017; 49: 695-714
• 2 Polkowski M, Jenssen C, Kaye P. et al. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) technical guidelines – March 2017. Endoscopy 2017; 49: 989-1006
• 3 Eloubeidi MA, Decker GA, Chandrasekhara V. et al. ASGE Standards of Practice Committee. The role of endoscopy in the evaluation and management of patients with solid pancreatic neoplasia. Gastrointest Endosc 2016; 83: 17-28
• 4 Hewitt MJ, McPhail MJ, Possamai L. et al. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc 2012; 275: 319-331
• 5 Puli SR, Bechtold ML, Buxbaum JL. et al. How good is endoscopic ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid pancreatic mass? A meta-analysis and systematic review. Pancreas 2013; 42: 20-26
• 6 Holt BA, Varadarajulu S, Herbert-Magee S. High-quality endoscopic ultrasound-guided fine needle aspiration tissue acquisition. Adv Ther 2014; 31: 696-707
• 7 Deshpande V, Mino-Kenudson M, Brugge WR. et al. Endoscopic ultrasound guided fine needle aspiration biopsy of autoimmune pancreatitis: diagnostic criteria and pitfalls. Am J Surg Pathol 2005; 29: 1464-1471
• 8 Brais RJ, Davies SE, O’Donovan M. et al. Direct histological processing of EUS biopsies enables rapid molecular biomarker analysis for interventional pancreatic cancer trials. Pancreatology 2012; 12: 8-15
• 9 Moffitt RA, Marayati R, Flate EL. et al. Virtual microdissection identifies distinct tumor and stroma specific subtypes of pancreatic ductal adenocarcinoma. Nat Genet 2015; 47: 1168-1178
• 10 Hébert-Magee S, Bae S, Varadarajulu S. et al. The presence of a cytopathologist increases the diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration cytology for pancreatic adenocarcinoma: a meta-analysis. Cytopathology 2013; 24: 159-171
• 11 Bang JY, Herbert-Magee S, Navaneethan U. et al. EUS-guided fine needle biopsy of pancreatic masses can yield true histology: results of a randomized trial. Gut 2017; [Epub ahead of print]
• 12 Bang JY, Hebert-Magee S, Hasan MK. et al. EUS-guided biopsy using a Franseen needle design: An initial assessment. Dig Endosc 2016; 29: 338-346
• 13 Di Mitri R, Rimbas M, Attili F. et al. Performance of a new needle for endoscopic ultrasound-guided fine-needle biopsy in patients with pancreatic solid lesions: A retrospective multicenter study. Endosc Ultrasound 2018; 7: 329-334
• 14 DiMaio CJ, Kolb JM, Benias PC. et al. Initial experience with a novel EUS-guided core biopsy needle (SharkCore): results of a large North American multicenter study. Endosc Int Open 2016; 9: E974-979
• 15 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
• 16 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
• 17 Bang JW, Hawes E, Varadarajulu S. A meta-analysis comparing Pro-Core and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy 2016; 48: 339-349
• 18 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
• 19 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: 13 (e0207)
• 20 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
• 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 Han P, Che D, Pallav K. et al. Models of the cutting edge geometry of medical needles with applications to needle design. Int J Mech Sci 2012; 65: 157-167
• 23 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
• 24 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
• 25 Chantrill LA, Nagrial AM, Watson C. et al. Precision medicine for advanced pancreas cancer: the individualized molecular pancreatic cancer therapy (IMPaCT) trial. Clin Cancer Res 2015; 21: 2029-2037
• 26 Early DS, Acosta RD, Chandrasekhara V. et al. ASGE Standards of Practice Committee. Adverse events associated with EUS and EUS with FNA. Gastrointest Endosc 2013; 77: 839-843