Subscribe to RSS
Histologic diagnosis of pancreatic masses using 25-gauge endoscopic ultrasound needles with and without a core trap: a multicenter randomized trial
submitted 08 May 2015
accepted after revision 23 February 2016
29 April 2016 (online)
Background and study aims: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) with 25-gauge needles yields small volume samples that are mainly processed for cytology. Using 25-gauge needles with a core trap may overcome this limitation. This trial compared 25-gauge needles with and without a core trap in terms of their ability to obtain histologic samples from solid pancreatic masses.
Patients and methods: Consecutive patients with solid pancreatic masses who presented to eight Japanese referral centers for EUS-FNA in April – September 2013 were randomized to undergo sampling with a 25-gauge needle with a core trap (ProCore) or a standard 25-gauge needle. Tissue samples were fixed in formalin and processed for histologic evaluation. For the purpose of this study only samples obtained with the first needle pass were used for comparison of: (i) accuracy for the diagnosis of malignancy, (ii) rate of samples with preserved tissue architecture adequate for histologic evaluation, and (iii) sample cellularity.
Results: A total of 214 patients were enrolled. Compared to the first pass with a standard needle (n = 108), the first pass with the ProCore needle (n = 106) provided samples that were more often adequate for histologic evaluation (81.1 % vs. 69.4 %; P = 0.048) and had superior cellularity (rich/moderate/poor, 36 %/27 %/37 % vs. 19 %/26 %/55 %; P = 0.003). There were no significant differences between the two needles in sensitivity (75.6 % vs. 69.0 %, P = 0.337) and accuracy (79.2 % vs. 75.9 %, P = 0.561) for the diagnosis of malignancy.
Conclusions: In patients with solid pancreatic masses, a 25-gauge EUS-FNA needle with a core trap provides histologic samples of better quality than a standard 25-gauge needle. There was no difference in accuracy for the diagnosis of malignancy between the needles. Clinical trial number: UMIN000010021.
- 1 Dumonceau JM, Polkowski M, Larghi A et al. Indication, 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 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
- 3 Itoi T, Sofuni A, Itokawa F et al. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc 2011; 23: 17-21
- 4 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
- 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; 48: 20-26
- 6 Siddiqui UD, Rossi F, Rosenthal LS et al. EUS-guided FNA of solid pancreatic masses: A prospective, randomized trial comparing 22-gaguge and 25-gauge needles. Gastrointest Endosc 2009; 70: 1093-1097
- 7 Yusuf TE, Ho S, Pavey DA et al. Retrospective analysis of the utility of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in pancreatic masses, using a 22-gauge or 25-gauge needle system: a multicenter experience. Endoscopy 2009; 41: 445-448
- 8 Nguyen TT, Lee CE, Whang CS et al. A comparison of the diagnostic yield and specimen adequacy between 22 and 25 gauge needles for endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) of solid pancreatic lesions (SPL): is big better?. Gastrointest Endosc 2008; 67: AB100
- 9 Lee JH, Stewart J, Ross WA et al. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci 2009; 54: 2274-2281
- 10 Madhoun MF, Wani SB, Rastogi A et al. The diagnostic accuracy of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis. Endoscopy 2013; 45: 86-92
- 11 Sakamoto H, Kitano M, Komaki 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 Song TJ, Kim JH, Lee SS et al. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol 2010; 105: 1739-1745
- 13 Wani S, Muthusamy VR, Komanduri S et al. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc 2014; 80: 939-959
- 14 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
- 15 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
- 16 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
- 17 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
- 18 Bang JY, Herbert-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
- 19 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
- 20 Iwashita T, Nakai Y, Samarasena JB et al. High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions. Gastrointest Endosc 2013; 7: 909-915
- 21 Kim GH, Cho YK, Kim EY et al. Comparison of 22-gauge aspiration needle with 22-gauge biopsy needle in endoscopic ultrasonography-guided subepithelial tumor sampling. Scand J Gastroenterol 2014; 49: 347-354
- 22 Nakai Y, Isayama H, Chang K et al. Slow pull versus suction in endoscopic ultrasound-guided fine-needle aspiration of pancreatic solid masses. Dig Dis Sci 2014; 59: 1578-1585
- 23 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