Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study

Background and study aims: A new core biopsy needle for endoscopic ultrasound (EUS)-guided sampling has recently been developed. The aim of this prospective multicenter study was to compare this needle with a standard needle in patients with solid pancreatic masses.

Patients and methods: Consecutive patients with solid pancreatic masses referred to 17 centers for EUS-guided sampling were included. Each patient had two passes with a standard 22G needle and a single pass with a 22G core needle performed in a randomized order. Samples from both needles were separately processed for liquid-based cytology and cell-block preparation and were assessed independently by two blinded expert pathologists. The primary endpoint was the accuracy of the detection of malignancy. The reference standard was based on further cytohistological analysis obtained under ultrasound or computed tomography scanning, endoscopic or surgical guidance, and/or by clinical follow-up with repeated imaging examinations for at least 12 months. The secondary endpoints were the rate of technical failure and the quality of the cytohistological samples obtained.

Results: Of the 80 patients included (49 men; mean age 67.1 ± 11.1), 87.5 % had final malignant diagnoses (adenocarcinoma n = 62, 77.5 %). There was no difference between the needles in diagnostic accuracy (standard needle 92.5 % vs. core needle 90 %; P = 0.68) or technical failure. Both pathologists found the overall sample quality significantly better for the standard needle (expert 1, P = 0.009; expert 2, P = 0.002).

Conclusions: The diagnostic accuracy of EUS sampling for solid pancreatic masses using standard and core needles seems comparable but with a better overall histological sample quality for the former.

ClinicalTrial.gov identifier: NCT01479803.

• References

• 1 Dumonceau JM, Polkowski M, Larghi A et al. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2011; 43: 897-912
• 2 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
• 3 Chen G, Liu S, Zhao Y et al. Diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration for pancreatic cancer: a meta-analysis. Pancreatology 2013; 13: 298-304
• 4 Hewitt MJ, McPhail MJ, Possamai L et al. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc 2012; 75: 319-331
• 5 Affolter KE, Schmidt RL, Matynia AP et al. Needle size has only a limited effect on outcomes in EUS-guided fine needle aspiration: a systematic review and meta-analysis. Dig Dis Sci 2013; 58: 1026-1034
• 6 Hartwig W, Schneider L, Diener MK et al. Preoperative tissue diagnosis for tumours of the pancreas. Br J Surg 2009; 96: 5-20
• 7 Siddiqui AA, Brown LJ, Hong SK et al. Relationship of pancreatic mass size and diagnostic yield of endoscopic ultrasound-guided fine needle aspiration. Dig Dis Sci 2011; 56: 3370-3375
• 8 Binmoeller KF, Rathod VD. Difficult pancreatic mass FNA: tips for success. Gastrointest Endosc 2002; 56: S86-S91
• 9 Gimeno-Garcia AZ, Elwassief A. How to improve the success of endoscopic ultrasound guided fine needle aspiration cytology in the diagnosis of pancreatic lesions. J Interv Gastroenterol 2012; 2: 31-36
• 10 Polkowski M, Larghi A, Weynand B et al. Learning, techniques, and complications of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline. Endoscopy 2012; 44: 190-206
• 11 Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I et al. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol 2011; 106: 1705-1710
• 12 Pellise UrquizaM, Fernandez-Esparrach G, Sole M et al. Endoscopic ultrasound-guided fine needle aspiration: predictive factors of accurate diagnosis and cost-minimization analysis of on-site pathologist. Gastroenterol Hepatol 2007; 30: 319-324
• 13 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
• 14 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
• 15 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
• 16 Mair S, Dunbar F, Becker PJ et al. Fine needle cytology--is aspiration suction necessary? A study of 100 masses in various sites. . Acta Cytol 1989; 33: 809-813
• 17 Eltoum IA, Chen VK, Chhieng DC et al. Probabilistic reporting of EUS-FNA cytology: Toward improved communication and better clinical decisions. Cancer 2006; 108: 93-101
• 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
• 19 Napoleon B, Alvarez-Sanchez MV, Gincoul R et al. Contrast-enhanced harmonic endoscopic ultrasound in solid lesions of the pancreas: results of a pilot study. Endoscopy 2010; 42: 564-570
• 20 Machin D. Sample size tables for clinical studies. 3rd edn. Chichester, UK. Hoboken, NJ: Wiley-Blackwell; 2008
• 21 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
• 22 Kopelman Y, Marmor S, Ashkenazi I et al. Value of EUS-FNA cytological preparations compared with cell block sections in the diagnosis of pancreatic solid tumours. Cytopathology 2011; 22: 174-178
• 23 Volmar KE, Vollmer RT, Routbort MJ et al. Pancreatic and bile duct brushing cytology in 1000 cases: review of findings and comparison of preparation methods. Cancer 2006; 108: 231-238
• 24 Larghi A, Iglesias-Garcia J, Poley JW et al. Feasibility and yield of a novel 22-gauge histology EUS needle in patients with pancreatic masses: a multicenter prospective cohort study. Surg Endosc 2013; 27: 3733-3738
• 25 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
• 26 LeBlanc JK, Ciaccia D, Al-Assi MT et al. Optimal number of EUS-guided fine needle passes needed to obtain a correct diagnosis. Gastrointest Endosc 2004; 59: 475-481
• 27 Moller K, Papanikolaou IS, Toermer T et al. EUS-guided FNA of solid pancreatic masses: high yield of 2 passes with combined histologic-cytologic analysis. Gastrointest Endosc 2009; 70: 60-69