Download PDF
CC BY-NC-ND 4.0 · Endosc Int Open 2019; 07(10): E1221-E1230
DOI: 10.1055/a-0982-2997
Original article
Owner and Copyright © Georg Thieme Verlag KG 2019

Diagnostic yield of Franseen and Fork-Tip biopsy needles for endoscopic ultrasound-guided tissue acquisition: a meta-analysis

Antonio Facciorusso
1   Gastroenterology Unit, University of Foggia, Italy
2   Biostatistics Unit, University of Foggia, Italy
,
Valentina Del Prete
1   Gastroenterology Unit, University of Foggia, Italy
,
Vincenzo Rosario Buccino
1   Gastroenterology Unit, University of Foggia, Italy
,
Purvi Purohit
2   Biostatistics Unit, University of Foggia, Italy
3   AIIMS, Jodhpur, India
,
Puneet Setia
2   Biostatistics Unit, University of Foggia, Italy
3   AIIMS, Jodhpur, India
,
Nicola Muscatiello
1   Gastroenterology Unit, University of Foggia, Italy
› Author Affiliations
Further Information

Publication History

submitted 15 April 2019

accepted after revision 05 July 2019

Publication Date:
01 October 2019 (online)

Also available at
   Permissions and Reprints

Abstract

Background and study aims Although newer needle designs are thought to improve diagnostic outcomes of endoscopic ultrasound-guided fine-needle biopsy, there is limited evidence on their diagnostic performance. The aim of this meta-analysis was to provide a pooled estimate of the diagnostic performance and safety profile of Franseen and Fork-tip fine-needle biopsy needles.

Patients and methods Computerized bibliographic search on the main databases was performed through March 2019. The primary endpoint was sample adequacy. Secondary outcomes were diagnostic accuracy, optimal histological core procurement, mean number of needle passes, pooled specificity and sensitivity. Safety data were also analyzed.

Results Twenty-four studies with 6641 patients were included and pancreas was the prevalent location of sampled lesions. Overall sample adequacy with the two newer needles was 94.8 % (93.1 % – 96.4 %), with superiority of Franseen needle over Fork-tip (96.1 % versus 92.4 %, P < 0.001). Sample adequacy in targeting pancreatic masses was 95.6% and both needles produced results superior to fine-needle aspiration (FNA) (odds ratio 4.29, 1.49 – 12.35 and 1.79, 1.01 – 3.19 with Franseen and Fork-tip needle, respectively). The rate of histological core procurement was 92.5%, whereas diagnostic accuracy and sensitivity were 95 % and 92.8 %, again with no difference between the two needles. Number of needle passes was significantly lower in comparison to FNA (mean difference: –0.42 with Franseen and –1.60 with Fork-tip needle). No significant adverse events were registered.

Conclusion Our meta-analysis speaks in favor of use of newer biopsy needles as a safe and effective tool in endoscopic ultrasound-guided tissue acquisition.

Supplementary Tables 1 – 5, Supplementary Figs. 1 – 6

 

  • References

  • 1 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
    CrossrefPubMedSearch in Google Scholar
  • 2 Wani S, Muthusamy VR, McGrath CM. et al. AGA White Paper: Optimizing Endoscopic Ultrasound-Guided Tissue Acquisition and Future Directions. Clin Gastroenterol Hepatol 2018; 16: 318-327
    CrossrefPubMedSearch in Google Scholar
  • 3 Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy 2016; 48: 339-349
    Thieme ConnectPubMedSearch in Google Scholar
  • 4 Facciorusso A, Singh Bajwa H, Menon K. et al. Comparison between 22-gauge aspiration and 22-gauge biopsy needles for eus-guided sampling of pancreatic lesions: a meta-analysis. Endosc Ultrasound 2019;
    CrossrefPubMedSearch in Google Scholar
  • 5 Higgins JP, Altman DG, Gøtzsche PC. et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928
    CrossrefPubMedSearch in Google Scholar
  • 6 Wells GA, Shea B, O’Connell D. et al. The Newcastle – Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. Available from: http://www.ohri.ca/programs/ clinical_epidemiology/oxford.htm , accessed on March 2019
    PubMed
  • 7 Reitsma JB, Glas AS, Rutjes AW. et al. Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. J Clin Epidemiol 2005; 58: 982-990
    CrossrefPubMedSearch in Google Scholar
  • 8 Shah ND, Sasatomi E, Baron TH. Endoscopic Ultrasound-guided Parenchymal Liver Biopsy: Single Center Experience of a New Dedicated Core Needle. Clin Gastroenterol Hepatol 2017; 15: 784-786
    CrossrefPubMedSearch in Google Scholar
  • 9 Bekkali NLH, Nayar MK, Leeds JS. et al. Impact of metal and plastic stents on endoscopic ultrasound-guided aspiration cytology and core histology of head of pancreas masses. Endoscopy 2019;
    Thieme ConnectPubMedSearch in Google Scholar
  • 10 Adler DG, Muthusamy VR, Ehrlich DS. et al. A multicenter evaluation of a new EUS core biopsy needle: Experience in 200 patients. Endosc Ultrasound 2019; 8: 99-104
    CrossrefPubMedSearch in Google Scholar
  • 11 Bang JY, Hebert-Magee S, Hasan MK. et al. Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment. Dig Endosc 2017; 29: 338-346
    CrossrefPubMedSearch in Google Scholar
  • 12 Haseeb A, Taylor LJ, Adler DG. Comparing endoscopic ultrasound-guided core biopsies of solid pancreatic and extrapancreatic lesions: a large single-operator experience with a new fine-needle biopsy needle. Ann Gastroenterol 2018; 31: 742-746
    PubMedSearch in Google Scholar
  • 13 Leung Ki EL, Lemaistre AI, Fumex F. et al. Macroscopic onsite evaluation using endoscopic ultrasound fine needle biopsy as an alternative to rapid onsite evaluation. Endosc Int Open 2019; 7: E189-E194
    Thieme ConnectPubMedSearch in Google Scholar
  • 14 Sugiura R, Kuwatani M, Yane K. et al. Prospective, multicenter, observational study of tissue acquisition through EUS-guided fine-needle biopsy using a 25G Franseen needle. Endosc Ultrasound 2019;
    CrossrefPubMedSearch in Google Scholar
  • 15 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
    CrossrefPubMedSearch in Google Scholar
  • 16 El Hajj II, Wu H, Reuss S. et al. Prospective Assessment of the Performance of a New Fine Needle Biopsy Device for EUS-Guided Sampling of Solid Lesions. Clin Endosc 2018; 51: 576-583
    CrossrefPubMedSearch in Google Scholar
  • 17 Fujita A, Ryozawa S, Kobayashi M. et al. Diagnostic ability of a 22G Franseen needle in endoscopic ultrasound-guided fine needle aspiration of subepithelial lesions. Mol Clin Oncol 2018; 9: 527-531
    PubMedSearch in Google Scholar
  • 18 Ishikawa T, Kawashima H, Ohno E. et al. Clinical Impact of EUS-Guided Fine Needle Biopsy Using a Novel Franseen Needle for Histological Assessment of Pancreatic Diseases. Can J Gastroenterol Hepatol 2019; 2019: 8581743
    PubMedSearch in Google Scholar
  • 19 Mukai S, Itoi T, Yamaguchi H. et al. A retrospective histological comparison of EUS-guided fine-needle biopsy using a novel franseen needle and a conventional end-cut type needle. Endosc Ultrasound 2019; 8: 50-57
    PubMedSearch in Google Scholar
  • 20 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; 4: E974-979
    Thieme ConnectPubMedSearch in Google Scholar
  • 21 Ishikawa T, Mohamed R, Heitman SJ. et al. Diagnostic yield of small histological cores obtained with a new EUS-guided fine needle biopsy system. Surg Endosc 2017; 31: 5143-5149
    CrossrefPubMedSearch in Google Scholar
  • 22 Larsen MH, Fristrup CW, Detlefsen S. et al. Prospective evaluation of EUS-guided fine needle biopsy in pancreatic mass lesions. Endosc Int Open 2018; 6: E242-E248
    Thieme ConnectPubMedSearch in Google Scholar
  • 23 El Chafic AH, Loren D, Siddiqui A. et al. Comparison of FNA and fine-needle biopsy for EUS-guided sampling of suspected GI stromal tumors. Gastrointest Endosc 2017; 86: 510-515
    CrossrefPubMedSearch in Google Scholar
  • 24 Jovani M, Abidi WM, Lee LS. 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
    CrossrefPubMedSearch in Google Scholar
  • 25 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
    CrossrefPubMedSearch in Google Scholar
  • 26 Naveed M, Siddiqui AA, Kowalski TE. et al. A Multicenter comparative trial of a novel EUS-guided core biopsy needle (SharkCore™) with the 22-gauge needle in patients with solid pancreatic mass lesions. Endosc Ultrasound 2018; 7: 34-40
    CrossrefPubMedSearch in Google Scholar
  • 27 Song Z, Trujillo CN, Song H. et al. Endoscopic Ultrasound-Guided Tissue Acquisition Using Fork-Tip Needle Improves Histological Yield, Reduces Needle Passes, Without On-Site Cytopathological Evaluation. J Pancreat Cancer 2018; 4: 75-80
    PubMedSearch in Google Scholar
  • 28 Witt BL, Factor RE, Chadwick BE. et al. Evaluation of the SharkCore® needle for EUS-guided core biopsy of pancreatic neuroendocrine tumors. Endosc Ultrasound 2018; 7: 323-328
    CrossrefPubMedSearch in Google Scholar
  • 29 Abdelfatah MM, Hamed A, Koutlas NJ. et al. The diagnostic and cellularity yield of reverse bevel versus fork-tip fine needle biopsy. Diagn Cytopathol 2018;
    CrossrefPubMedSearch in Google Scholar
  • 30 Nayar MK, Paranandi B, Dawwas MF. et al. 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
    CrossrefPubMedSearch in Google Scholar
  • 31 Bang JY, Kirtane S, Krall K. et al. In memoriam - fine needle aspiration, Birth - fine needle biopsy:The changing trend in endoscopic ultrasound-guided tissue acquisition. Dig Endosc 2018;
    CrossrefPubMedSearch in Google Scholar
  • 32 Abdelfatah MM, Grimm IS, Gangarosa LM. et al. Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles. Gastrointest Endosc 2018; 87: 495-500
    CrossrefPubMedSearch in Google Scholar
  • 33 Bang JY, Hebert-Magee S, Navaneethan U. et al. EUS-guided fine needle biopsy of pancreatic masses can yield true histology: results of a randomised trial. Gut 2017; 67: 2081-2084
    PubMedSearch in Google Scholar
  • 34 Facciorusso A, Buccino RV, Muscatiello N. How to measure quality in endoscopic ultrasound. Ann Transl Med 2018; 6: 266
    CrossrefPubMedSearch in Google Scholar
  • 35 James TW, Baron TH. A comprehensive review of endoscopic ultrasound core biopsy needles. Expert Rev Med Devices 2018; 15: 127-135
    CrossrefPubMedSearch in Google Scholar
  • 36 Song F, Loke YK, Walsh T. et al. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ 2009; 338: b1147
    CrossrefPubMedSearch in Google Scholar