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Endoscopy 2022; 54(01): 4-12
DOI: 10.1055/a-1375-9775
Original article

Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial

Yen-I Chen 
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Avijit Chatterjee
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Robert Berger
3   Division of Gastroenterology, Moncton Hospital, Moncton, New Brunswick, Canada
,
Yonca Kanber
4   Department of Pathology, McGill University Health Centre, Montreal, Quebec, Canada
,
Jonathan Wyse
5   Division of Gastroenterology and Hepatology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
,
Eric Lam
6   Division of Gastroenterology and Hepatology, St-Paul Hospital, Vancouver, British Columbia, Canada
,
Ian Gan
7   Division of Gastroenterology and Hepatology, Vancouver General Hospital, Vancouver, British Columbia, Canada
,
Manon Auger
4   Department of Pathology, McGill University Health Centre, Montreal, Quebec, Canada
,
Sana Kenshil
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Jennifer Telford
6   Division of Gastroenterology and Hepatology, St-Paul Hospital, Vancouver, British Columbia, Canada
,
Fergal Donnellan
7   Division of Gastroenterology and Hepatology, Vancouver General Hospital, Vancouver, British Columbia, Canada
,
James Quinlan
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Gregory Lutzak
8   Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada
,
Fatma Alshamsi
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Josee Parent
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Kevin Waschke
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Adel Alghamdi
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Jeffrey Barkun
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Peter Metrakos
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Prosanto Chaudhury
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Myriam Martel
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Alastair Dorreen
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Kristen Candido
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Corey Miller 
5   Division of Gastroenterology and Hepatology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
,
Viviane Adam
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Alan Barkun
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
George Zogopoulos
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Clarence Wong
8   Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada
› Author AffiliationsTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03435588 Type of study: Multicenter randomized controlled trial
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With or without ROSE: does fine-needle biopsy settle the debate on rapid on-site evaluation?Endoscopy 2022; 54(01): 13-15
DOI: 10.1055/a-1513-0564

Abstract

Background Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA + ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions.

Methods A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost.

Results 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA + ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA + ROSE at 92.2 % (95 %CI 86.6 %–96.9 %) and 93.3 % (95 %CI 88.8 %–97.9 %), respectively (P = 0.72). Diagnostic sensitivity for malignancy was 92.5 % (95 %CI 85.7 %–96.7 %) for EUS-FNB alone vs. 96.5 % (93.0 %–98.6 %) for EUS-FNA + ROSE (P = 0.46), while specificity was 100 % in both. Adequate histological yield was obtained in 87.5 % of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [P < 0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [P = 0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNA + ROSE.

Conclusion EUS-FNB alone is non-inferior to EUS-FNA + ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.



Publication History

Received: 10 September 2020

Accepted after revision: 27 January 2021

Accepted Manuscript online:
27 January 2021

Article published online:
15 April 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Committee ASoP, Eloubeidi MA, Decker GA. et al. The role of endoscopy in the evaluation and management of patients with solid pancreatic neoplasia. Gastrointest Endosc 2016; 83: 17-28
    CrossrefPubMedGoogle Scholar
  • 2 Jenssen C, Hocke M, Fusaroli P. et al. EFSUMB guidelines on interventional ultrasound (INVUS), Part IV - EUS-guided interventions: General aspects and EUS-guided sampling (Short Version). Ultraschall Med 2016; 37: 157-169
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Klapman JB, Logrono R, Dye CE. et al. Clinical impact of on-site cytopathology interpretation on endoscopic ultrasound-guided fine needle aspiration. Am J Gastroenterol 2003; 98: 1289-1294
    CrossrefPubMedGoogle Scholar
  • 4 Kulesza P, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration: sampling, pitfalls, and quality management. Clin Gastroenterol Hepatol 2007; 5: 1248-1254
    CrossrefPubMedGoogle Scholar
  • 5 Ashat M, Klair JS, Rooney SL. et al. Randomized controlled trial comparing the Franseen needle with a Fork-tip needle for EUS-guided fine-needle biopsy. Gastrointest Endosc 2021; 93: 140-150
    CrossrefPubMedGoogle Scholar
  • 6 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
    CrossrefPubMedGoogle Scholar
  • 7 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 Guideline – March 2017. Endoscopy 2017; 49: 989-1006
    Article in Thieme ConnectPubMedGoogle Scholar
  • 8 Guo J, Sahai AV, Teoh A. et al. An international, multi-institution survey on performing EUS-FNA and fine needle biopsy. Endosc Ultrasound 2020; 9: 319-328
    CrossrefPubMedGoogle Scholar
  • 9 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
    CrossrefPubMedGoogle Scholar
  • 10 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
    CrossrefPubMedGoogle Scholar
  • 11 Gerke H, Rizk MK, Vanderheyden AD. et al. Randomized study comparing endoscopic ultrasound-guided Trucut biopsy and fine needle aspiration with high suction. Cytopathology 2010; 21: 44-51
    CrossrefPubMedGoogle Scholar
  • 12 Drummond MF, Sculpher MJ, Torrance GW. et al. Methods for the economic evaluation of health care programmes. 2nd edn. Oxford University Press; 2005: 379
    Google Scholar
  • 13 Centers for Medicare and Medicaid Services. Accessed: June 2020. Available from: https://www.cms.gov/
    PubMedGoogle Scholar
  • 14 U.S. Bureau of Labor Statistics. Accessed: June 2020. Available from: http://www.bls.gov/
    PubMedGoogle Scholar
  • 15 Schedule of Benefits and fees, Ministry of Health, Ontario. Accessed: June 2020. Available from: http: //www.health.gov.on.ca/en/pro/programs/ohip/sob/
    PubMedGoogle Scholar
  • 16 Statistics Canada. Accessed: June 2020. Available from: https://www.statcan.gc.ca/
    PubMedGoogle Scholar
  • 17 Purchasing Department, McGill University Health Center, Montreal, Canada. Accessed: June 2020. Available from: https://muhc.ca/glen
    PubMedGoogle Scholar
  • 18 Lee LS, Nieto J, Watson RR. et al. Randomized noninferiority trial comparing diagnostic yield of cytopathologist-guided versus 7 passes for EUS-FNA of pancreatic masses. Dig Endosc 2016; 28: 469-475
    CrossrefPubMedGoogle Scholar
  • 19 Dumonceau JM, Koessler T, van Hooft JE. et al. Endoscopic ultrasonography-guided fine needle aspiration: Relatively low sensitivity in the endosonographer population. World J Gastroenterol 2012; 18: 2357-2363
    CrossrefPubMedGoogle Scholar
  • 20 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
    CrossrefPubMedGoogle Scholar
  • 21 van Riet PA, Larghi A, Attili F. et al. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointest Endosc 2019; 89: 329-339
    CrossrefPubMedGoogle Scholar
  • 22 Bang JY, Hebert-Magee S, Navaneethan U. et al. EUS-guided fine needle biopsy of pancreatic masses can yield true histology. Gut 2018; 67: 2081-2084
    CrossrefPubMedGoogle Scholar
  • 23 Heymann JJ, Siddiqui MT. Ancillary techniques in cytologic specimens obtained from solid lesions of the pancreas: a review. Acta Cytol 2020; 64: 103-123
    CrossrefPubMedGoogle Scholar
  • 24 Wyse JM, Carone M, Paquin SC. et al. Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. J Clin Oncol 2011; 29: 3541-3546
    CrossrefPubMedGoogle Scholar