Comparison of 22-gauge standard and Franseen needles in EUS-guided tissue acquisition for diagnosing solid pancreatic lesions: a multicenter randomized controlled trial

Published:February 10, 2022DOI:https://doi.org/10.1016/j.gie.2022.02.005

      Background and Aims

      This large multicenter randomized controlled trial compared the diagnostic yields of 22-gauge standard and 22-gauge Franseen needles for EUS-guided tissue acquisition (EUS-TA) of solid pancreatic lesions.

      Methods

      Consecutive patients with solid pancreatic lesions were prospectively randomized to EUS-TA using standard or Franseen needles. Samples obtained with the first needle pass and with second and subsequent passes were evaluated separately. The primary endpoint was the rate of accuracy for diagnosis of malignancy. Other endpoints were technical success rate, sample cellularity, adverse events, diagnostic accuracy in patient subgroups, and the diagnostic accuracy and numbers of second and subsequent needle passes.

      Results

      Of 523 patients undergoing EUS-TA, 260 were randomized to using standard 22-gauge needles and 263 to 22-gauge Franseen needles. The technical success rate in each group was 99.6%, with similar adverse event rates in the standard (1.5%) and Franseen (.8%) needle groups. First-pass EUS-TA using the Franseen needle resulted in significantly greater diagnostic accuracy (84.0% vs 71.2%, P < .001) and sensitivity (82.4% vs 66.7%, P < .001) than first-pass EUS-TA using a standard needle and also resulted in superior diagnostic accuracy in patients requiring immunostaining. Second and subsequent EUS-TA using Franseen needles showed significantly greater accuracy (94.7% vs 90.0%, P = .049) and sensitivity (94.0% vs 88.6%, P = .047) and required fewer needle passes (1.81 vs 2.03, P = .008) than using standard needles.

      Conclusions

      EUS-TA with the Franseen needle is superior to EUS-TA with a standard needle with respect to diagnostic accuracy per pass, particularly in patients who require immunostaining, and number of passes when using macroscopic on-site evaluation. (Clinical trial registration numbers: UMIN000030634 and jRCTs052180062.)

      Graphical abstract

      Abbreviations:

      EUS-TA (EUS-guided tissue acquisition), FNB (fine-needle biopsy), MOSE (macroscopic on-site evaluation), RCT (randomized controlled trial), ROSE (rapid on-site evaluation)
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      References

        • Volmar K.E.
        • Vollmer R.T.
        • Jowell P.S.
        • et al.
        Pancreatic FNA in 1000 cases: a comparison of imaging modalities.
        Gastrointest Endosc. 2005; 61: 854-861
        • Iglesias-Garcia J.
        • Dominguez-Munoz J.E.
        • 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
        • Iwashita T.
        • Nakai Y.
        • Samarasena J.B.
        • 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; 77: 909-915
        • Bang J.Y.
        • 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
        • 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
        • Inoue T.
        • Okumura F.
        • Mizushima T.
        • et al.
        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
        • 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
        • Kurita A.
        • Yasukawa S.
        • Zen Y.
        • et al.
        Comparison of a 22-gauge Franseen-tip needle with a 20-gauge forward-bevel needle for the diagnosis of type 1 autoimmune pancreatitis: a prospective, randomized, controlled, multicenter study (COMPAS study).
        Gastrointest Endosc. 2020; 91: 373-381
        • Ishigaki K.
        • Nakai Y.
        • Sasahira N.
        • et al.
        A prospective multicenter study of endoscopic ultrasound-guided fine needle biopsy using a 22-gauge Franseen needle for pancreatic solid lesions.
        J Gastroenterol Hepatol. 2021; 36: 2754-2761
        • Facciorusso A.
        • Sunny S.P.
        • Del Prete V.
        • et al.
        Comparison between fine-needle biopsy and fine-needle aspiration for EUS-guided sampling of subepithelial lesions: a meta-analysis.
        Gastrointest Endosc. 2020; 91: 14-22
        • van Riet P.A.
        • Erler N.S.
        • Bruno M.J.
        • et al.
        Comparison of fine-needle aspiration and fine-needle biopsy devices for endoscopic ultrasound-guided sampling of solid lesions: a systemic review and meta-analysis.
        Endoscopy. 2020; 53: 411-423
        • Facciorusso A.
        • Wani S.
        • Triantafyllou K.
        • et al.
        Comparative accuracy of needle sizes and designs for EUS tissue sampling of solid pancreatic masses: a network meta-analysis.
        Gastrointest Endosc. 2019; 90: 893-903
        • Itonaga M.
        • Yasukawa S.
        • Shimokawa T.
        • et al.
        Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: study protocol for a controlled trial.
        Trials. 2019; 20: 816
        • Iwashita T.
        • Yasuda I.
        • Mukai T.
        • et al.
        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
        • Kamata K.
        • Kitano M.
        • Yasukawa S.
        • et al.
        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
        • van Riet P.A.
        • 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
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Facciorusso A.
        • Bajwa H.S.
        • Menon K.
        • et al.
        Comparison between 22G aspiration and 22G biopsy needles for EUS-guided sampling of pancreatic lesions: a meta-analysis.
        Endosc Ultrasound. 2020; 9: 167-174
        • Li H.
        • Li W.
        • Zhou Q.Y.
        • et al.
        Fine needle biopsy is superior to fine needle aspiration in endoscopic ultrasound guided sampling of pancreatic masses: a meta-analysis of randomized controlled trials.
        Medicine (Baltimore). 2018; 97: e0207
        • Wang J.
        • Zhao S.
        • Chen Y.
        • et al.
        Endoscopic ultrasound guided fine needle aspiration versus endoscopic ultrasound guided fine needle biopsy in sampling pancreatic masses: a meta-analysis.
        Medicine (Baltimore). 2017; 96: e7452
        • Alatawi A.
        • Beuvon F.
        • Grabar S.
        • et al.
        Comparison of 22G reverse-beveled versus standard needle for endoscopic ultrasound-guided sampling of solid pancreatic lesions.
        United Eur Gastroenterol J. 2015; 3: 343-352
        • 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
        • Noh D.H.
        • Choi K.
        • Gu S.
        • et al.
        Comparison of 22-gauge standard fine needle versus core biopsy needle for endoscopic ultrasound-guided sampling of suspected pancreatic cancer: a randomized crossover trial.
        Scand J Gastroenterol. 2018; 53: 94-99
        • Oppong K.W.
        • Bekkali N.L.H.
        • Leeds J.S.
        • et al.
        Fork-tip needle biopsy versus fine-needle aspiration in endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized crossover study.
        Endoscopy. 2020; 52: 454-461
        • Bang J.Y.
        • Hebert-Magee S.
        • Navaneethan U.
        • et al.
        EUS-guided fine needle biopsy of pancreatic masses can yield true histology.
        Gut. 2018; 67: 2081-2084
        • Ishigaki K.
        • Nakai Y.
        • Oyama H.
        • et al.
        Endoscopic ultrasound-guided tissue acquisition by 22-gauge Franseen and standard needles for solid pancreatic lesions.
        Gut Liver. 2020; 14: 817-825
        • Song T.J.
        • Kim J.H.
        • Lee S.S.
        • 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
        • Elhanafi S.
        • Mahmud N.
        • Vergara N.
        • et al.
        Comparison of endoscopic ultrasound tissue acquisition methods for genomic analysis of pancreatic cancer.
        J Gastroenterol Hepatol. 2019; 34: 907-913
        • Chong C.C.N.
        • Lakhtakia S.
        • Nguyen N.
        • et al.
        Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial.
        Endoscopy. 2020; 52: 856-863