Background and Aims
Several studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none
have proven superiority. We performed a multicenter randomized controlled trial to
compare the performance of a commonly used 25-gauge FNA needle with a newly designed
20-gauge FNB needle.
Methods
Consecutive patients with a solid lesion were randomized in this international multicenter
study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The
primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification
(non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample
quality were also assessed. Multivariable and supplementary analyses were performed
to adjust for confounders.
Results
A total of 608 patients were allocated to FNA (n = 306) or FNB (n = 302); 312 pancreatic
lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success
rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P = .043), with no differences in adverse events. The 20-gauge FNB needle outperformed
25-gauge FNA in terms of histologic yield (77% vs 44%, P < .001), accuracy for malignancy (87% vs 78%, P = .002) and Bethesda classification (82% vs 72%, P = .002). This was robust when corrected for indication, lesion size, number of passes,
and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval,
1.55-8.56; P = .004), and did not differ among centers (P = .836).
Conclusion
The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic
yield and diagnostic accuracy. This benefit was irrespective of the indication and
was consistent among participating centers, supporting the general applicability of
our findings. (Clinical trial registration number: NCT02167074.)
Abbreviations:
FNB (fine-needle biopsy), ROSE (rapid on-site pathology evaluation)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Gastrointestinal EndoscopyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- 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
- 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
- High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions.Gastrointestinal Endosc. 2013; 77: 909-915
- 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
- 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
- Assessment of factors affecting the usefulness and diagnostic yield of core biopsy needles with a side hole in endoscopic ultrasound-guided fine-needle aspiration.Gut Liver. 2016; 10: 51-57
- A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition.Endoscopy. 2016; 48: 339-349
- Feasibility and efficiency of a new 22G core needle: a prospective comparison study.Endoscopy. 2013; 45: 792-798
- 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
- Endoscopic ultrasound-guided FNA and ProCore biopsy in sampling pancreatic and intra-abdominal masses.Cancer Cytopathol. 2016; 124: 110-121
- Histologic diagnosis of pancreatic masses using 25-gauge endoscopic ultrasound needles with and without a core trap: a multicenter randomized trial.Endoscopy. 2016; 48: 632-638
- 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
- Comparison of histologic core portions acquired from a core biopsy needle and a conventional needle in solid mass lesions: a prospective randomized trial.Gut Liver. 2017; 11: 559-566
- 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
- Multicentre randomised trial comparing EUS guided fine needle aspiration cytology (FNAC) with fine needle aspiration biopsy (FNA B) in sampling solid pancreatic mass lesions: preliminary results from the ProCore trial.Gut. 2015; 64: A213
- The cellularity yield of three different 22-gauge endoscopic ultrasound fine needle aspiration needles.Diagn Cytopathol. 2017; 45: 426-432
- Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study.Endoscopy. 2014; 46: 1063-1070
- Comparing endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) versus fine needle biopsy (FNB) in the diagnosis of solid lesions: study protocol for a randomized controlled trial.Trials. 2016; 17: 198
- Analysis of fine-needle biopsy versus fine-needle aspiration in diagnosis of pancreatic and abdominal masses: a prospective, multicenter, randomized controlled trial.Clin Gastroenterol Hepatol. 2018; 16: 1314-1321
- Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017.Endoscopy. 2017; 49: 989-1006
- Clinical trials: a practical approach.John Wiley, Chichester1983
- The path to personalized medicine.Curr Opin Chem Biol. 2002; 6: 434-438
- Role of endoscopic ultrasound in the molecular diagnosis of pancreatic cancer.World J Gastroenterol. 2014; 20: 10758-10768
- Precision medicine--personalized, problematic, and promising.N Engl J Med. 2015; 372: 2229-2234
- Endoscopic ultrasound pin-points the precision medicine for pancreatic cancer.Endosc Ultrasound. 2016; 5: 1-3
- Mapping international practice patterns in EUS-guided tissue sampling: outcome of a global survey.Endosc Int Open. 2016; 4: E360-E370
- 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
- A prospective randomized study comparing 25-G and 22-G needles of a new platform for endoscopic ultrasound-guided fine needle aspiration of solid masses.Dig Liver Dis. 2016; 48: 49-54
- 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
- Comparison of two different size needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing solid pancreatic lesions: a meta-analysis of prospective controlled trials.Medicine (Baltimore). 2017; 96: e5802
- Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.Endoscopy. 2018; 50: 497-504
- Standardized terminology and nomenclature for pancreatobiliary cytology: the Papanicolaou Society of Cytopathology Guidelines.Cytojournal. 2014; 11: 3
- WHO classification of tumours of the digestive system.4th ed. IARC Press, Lyon2010
- Diagnosis of gastrointestinal stromal tumors: a consensus approach.Hum Pathol. 2002; 33: 459-465
- 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
- Prospective study for comparison of endoscopic ultrasound-guided tissue acquisition using 25- and 22-gauge core biopsy needles in solid pancreatic masses.PLoS One. 2016; 11: e0154401
- Endoscopic ultrasound-guided fine needle aspiration of pancreatic lesions with 22 versus 25 Gauge needles: a meta-analysis.United European Gastroenterol J. 2017; 5: 846-853
- Linear mixed models for longitudinal data.Springer, New York2009
- Definitions in tissue acquisition: core biopsy, cell block, and beyond.Gastrointest Endosc Clin N Am. 2014; 24: 19-27
- EUS-guided fine-needle aspiration combined with flow cytometry and immunocytochemistry in the diagnosis of lymphoma.Gastrointest Endosc. 2001; 53: 485-491
- Utilization of ancillary studies in the cytologic diagnosis of biliary and pancreatic lesions: the Papanicolaou Society of Cytopathology Guidelines.Cytojournal. 2014; 11: 4
- Fine-needle aspiration biopsy of pancreatic neuroendocrine tumors: correlation between Ki-67 index in cytological samples and clinical behavior.Diagn Cytopathol. 2017; 45: 29-35
- Endoscopic ultrasound core needle for diagnosing of solid pancreatic lesions: is rapid on- site evaluation really necessary?.Minerva Med. 2017; 108: 547-553
- The presence of rapid on-site evaluation did not increase the adequacy and diagnostic accuracy of endoscopic ultrasound-guided tissue acquisition of solid pancreatic lesions with core needle.Surg Endosc. 2017; 31: 225-230
- EUS-guided fine needle biopsy of pancreatic masses can yield true histology: results of a randomised trial.Gut. 2017; https://doi.org/10.1136/gutjnl-2017-31515
- 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
- Diagnostic yield and safety of endoscopic ultrasound-guided trucut [corrected] biopsy in patients with gastric submucosal tumors: a prospective study.Endoscopy. 2009; 41: 329-334
- 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
- Rapid on-site evaluation does not improve endoscopic ultrasound-guided fine needle aspiration adequacy in pancreatic masses: a meta-analysis and systematic review.PLoS One. 2016; 11: e0163056
- Rapid on-site evaluation during endoscopic ultrasound-guided fine-needle aspiration of lymph nodes does not increase diagnostic yield: a randomized, multicenter trial.Am J Gastroenterol. 2018; 113: 677-685
- 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
- Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions.Gastrointest Endosc. 2017; 85: 1017-1024
- Initial experience with a novel EUS-guided core biopsy needle (SharkCore): results of a large North American multicenter study.Endosc Int Open. 2016; 4: E974-E979
- Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study.Scand J Gastroenterol. 2017; 52: 784-787
- Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment.Dig Endosc. 2017; 29: 338-346
Article info
Publication history
Published online: October 24, 2018
Accepted:
October 11,
2018
Received:
July 14,
2018
Footnotes
If you would like to chat with an author of this article, you may contact Dr van Riet at [email protected]
DISCLOSURE: Dr van Riet was a consultant for Cook Medical Devices during United European Gastroenterology Week in 2016. Dr Robert has participated in Speakers Bureau (Merck), Beyond Celiac Foundation, and a clinical trial on pancreas cancer (Bayer). Dr Chang is a consultant for and has received educational grants from Cook Medical and Olympus. Dr Bories is a consultant for Cook Medical and Pentax. Dr Poley is a consultant for and has received speaker's fees and travel arrangements from Cook Medical, Boston Scientific, and Pentax. Dr Baldaque-Silva is a consultant for Boston Scientific and has received travel reimbursement from Olympus. Dr Bruno is a consultant and lectures for Cook Medical and a consultant and lectures for Boston Scientific.
See CME Section; p. 383.
Identification
Copyright
© 2019 by the American Society for Gastrointestinal Endoscopy
