Randomized controlled trial comparing the Franseen needle with the Fork-tip needle for EUS-guided fine-needle biopsy

      Background and Aims

      EUS-guided FNA primarily provides cytologic samples. EUS-guided fine-needle biopsy (FNB) with needles that provide histologic specimens may enhance diagnostic yield and facilitate accessory tissue staining. Several different needle designs are currently available and design superiority is unknown. We designed a randomized controlled trial to compare 2 commonly used EUS-FNB needles in their ability to provide histologic tissue samples (primary endpoint) and to reach an accurate diagnosis (secondary endpoint).

      Methods

      A total of 150 lesions from 134 patients (November 2018 to June 2019) were randomized 1:1 between biopsy with a Franseen needle and a Fork-tip needle. The groups were compared regarding the quality of the tissue samples and diagnostic accuracy.

      Results

      Of 150 lesions, 75 were pancreatic and 75 were other solid lesions in and around the GI tract. There was no statistically significant difference between the Franseen needle and the Fork-tip needle in the yield of adequate histologic samples, 71 of 75 (94.7%) versus 72 of 75 (96%), (P = 1.00), an absolute difference of −1.3% (95% confidence interval [CI], −8.1% to 5.4%). The 2 groups were similar in the diagnostic accuracy of histologic analysis, 64 of 75 (85.3%) versus 68 of 75 (90.7%) (P = .45), absolute difference −5.4% (95% CI, −15.7% to 5%); and in the diagnostic accuracy of combined cytologic and histologic analysis, 65 of 75 (86.7%) versus 69 of 75 (92%) (P = .43), absolute difference −5.3% (95% CI, −15.2% to 4.5%).

      Conclusions

      There was no significant difference in the performance of the Franseen needle versus the Fork-tip needle. Both needles achieved a high yield of histologic tissue samples and high diagnostic accuracy. (Clinical trial registration number: NCT03672032.)

      Graphical abstract

      Abbreviations:

      CI (confidence interval), IQR (interquartile range), ROSE (rapid on-site 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 access
      One-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 Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Yoshinaga S.
        • Suzuki H.
        • Oda I.
        • et al.
        Role of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for diagnosis of solid pancreatic masses.
        Dig Endosc. 2011; 23: 29-33
        • Hewitt M.J.
        • McPhail M.J.
        • Possamai L.
        • et al.
        EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis.
        Gastrointest Endosc. 2012; 75: 319-331
        • Gleeson F.C.
        • Kipp B.R.
        • Caudill J.L.
        • et al.
        False positive endoscopic ultrasound fine needle aspiration cytology: incidence and risk factors.
        Gut. 2010; 59: 586-593
        • Ieni A.
        • Todaro P.
        • Crino S.F.
        • et al.
        Endoscopic ultrasound-guided fine-needle aspiration cytology in pancreaticobiliary carcinomas: diagnostic efficacy of cell-block immunocytochemistry.
        Hepatobiliary Pancreat Dis Int. 2015; 14: 305-312
        • Yan B.M.
        • Pai R.K.
        • Van Dam J.
        Diagnosis of pancreatic gastrointestinal stromal tumor by EUS guided FNA.
        JOP. 2008; 9: 192-196
        • Levy M.J.
        Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and problems.
        Pancreatology. 2007; 7: 163-166
        • Klapman J.B.
        • Logrono R.
        • Dye C.E.
        • et al.
        Clinical impact of on-site cytopathology interpretation on endoscopic ultrasound-guided fine needle aspiration.
        Am J Gastroenterol. 2003; 98: 1289-1294
        • Khan M.A.
        • Grimm I.S.
        • Ali B.
        • et al.
        A meta-analysis of endoscopic ultrasound-fine-needle aspiration compared to endoscopic ultrasound-fine-needle biopsy: diagnostic yield and the value of onsite cytopathological assessment.
        Endosc Int Open. 2017; 5: E363-E375
        • Machicado J.D.
        • Thosani N.
        • Wani S.
        Will abandoning fine-needle aspiration increase diagnostic yield from tissues collected during endoscopic ultrasound?.
        Clin Gastroenterol Hepatol. 2018; 16: 1203-1206
        • Bang J.Y.
        • 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
        • 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 European Gastroenterol J. 2015; 3: 343-352
        • Bang J.Y.
        • 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
        • Aadam A.A.
        • Wani S.
        • Amick A.
        • et al.
        A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy.
        Endosc Int Open. 2016; 4: E497-505
        • 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
        • Sandhu D.S.
        • Holm A.N.
        • El-Abiad R.
        • et al.
        Endoscopic ultrasound with tissue sampling is accurate in the diagnosis and subclassification of gastrointestinal spindle cell neoplasms.
        Endosc Ultrasound. 2017; 6: 174-180
        • Hedenstrom P.
        • Marschall H.U.
        • Nilsson B.
        • et al.
        High clinical impact and diagnostic accuracy of EUS-guided biopsy sampling of subepithelial lesions: a prospective, comparative study.
        Surg Endosc. 2018; 32: 1304-1313
        • Rodrigues-Pinto E.
        • Jalaj S.
        • Grimm I.S.
        • et al.
        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
        • Cohen M.B.
        • Egerter D.P.
        • Holly E.A.
        • et al.
        Pancreatic adenocarcinoma: regression analysis to identify improved cytologic criteria.
        Diagn Cytopathol. 1991; 7: 341-345
        • Schwartz D.A.
        • Unni K.K.
        • Levy M.J.
        • et al.
        The rate of false-positive results with EUS-guided fine-needle aspiration.
        Gastrointest Endosc. 2002; 56: 868-872
        • Siddiqui A.A.
        • Kowalski T.E.
        • Shahid H.
        • et al.
        False-positive EUS-guided FNA cytology for solid pancreatic lesions.
        Gastrointest Endosc. 2011; 74: 535-540
        • Ashat M.
        • Soota K.
        • Klair J.S.
        • et al.
        Modified EUS needle to obtain histological core tissue samples: a retrospective analysis.
        Clin Endosc. 2020; https://doi.org/10.5946/ce.2019.108
        • Banks P.A.
        • Bollen T.L.
        • Dervenis C.
        • et al.
        Classification of acute pancreatitis—2012: revision of the Atlanta classification and definitions by international consensus.
        Gut. 2013; 62: 102-111
        • Varadarajulu S.
        • Bang J.Y.
        • Hebert-Magee S.
        Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle.
        Gastrointest Endosc. 2012; 76: 336-343
        • Larghi A.
        • Verna E.C.
        • Ricci R.
        • et al.
        EUS-guided fine-needle tissue acquisition by using a 19-gauge needle in a selected patient population: a prospective study.
        Gastrointest Endosc. 2011; 74: 504-510
        • 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
        • 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
        • Gerke H.
        • Rizk M.K.
        • Vanderheyden A.D.
        • et al.
        Randomized study comparing endoscopic ultrasound-guided Trucut biopsy and fine needle aspiration with high suction.
        Cytopathology. 2010; 21: 44-51
        • Naveed M.
        • Siddiqui A.A.
        • Kowalski T.E.
        • 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
        • DiMaio C.J.
        • Kolb J.M.
        • Benias P.C.
        • 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-E979
        • Witt B.L.
        • Factor R.E.
        • Chadwick B.E.
        • et al.
        Evaluation of the SharkCore(I) needle for EUS-guided core biopsy of pancreatic neuroendocrine tumors.
        Endosc Ultrasound. 2018; 7: 323-328
        • El Chafic A.H.
        • 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
        • Yasuda I.
        • Tsurumi H.
        • Omar S.
        • et al.
        Endoscopic ultrasound-guided fine-needle aspiration biopsy for lymphadenopathy of unknown origin.
        Endoscopy. 2006; 38: 919-924
        • Manfrin E.
        • Perini C.
        • Di Stefano S.
        • et al.
        Pseudo solid-appearing pancreatic serous microcystic adenomas: Histologic diagnosis with the EUS core biopsy fork-tip needle.
        Endosc Ultrasound. 2019; 8: 334-341
        • Wani S.
        • Muthusamy V.R.
        • Komanduri S.
        EUS-guided tissue acquisition: an evidence-based approach (with videos).
        Gastrointest Endosc. 2014; 80: 939-959.e7
        • Fabbri C.
        • Fuccio L.
        • Fornelli A.
        • et al.
        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
        • 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
        • Wittmann J.
        • Kocjan G.
        • Sgouros S.N.
        • et al.
        Endoscopic ultrasound-guided tissue sampling by combined fine needle aspiration and trucut needle biopsy: a prospective study.
        Cytopathology. 2006; 17: 27-33
        • Abdelfatah M.M.
        • Grimm I.S.
        • Gangarosa L.M.
        • et al.
        Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles.
        Gastrointest Endosc. 2018; 87: 495-500
        • LeBlanc J.K.
        • Ciaccia D.
        • Al-Assi M.T.
        • et al.
        Optimal number of EUS-guided fine needle passes needed to obtain a correct diagnosis.
        Gastrointest Endosc. 2004; 59: 475-481
        • Saxena P.
        • El Zein M.
        • Stevens T.
        • et al.
        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

      Linked Article

      • Franseen versus fork-tip: Crowning the king of crown-cut needles?
        Gastrointestinal EndoscopyVol. 93Issue 1
        • Preview
          EUS-guided tissue acquisition is a widely accepted and invaluable method for diagnosing masses within and adjacent to the upper GI tract and mediastinum. The first needle developed for this purpose had a simple design with a beveled tip and was mainly used to obtain cytologic material (FNA).1,2 The efficacy of FNA needles was subsequently confirmed in numerous studies that reported sensitivity rates >90% and specificity close to 100%.3-5 However, in subepithelial lesions, these needles perform rather moderately (diagnostic accuracy 67% to 84%).
        • Full-Text
        • PDF