EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial

Abstract

Background and study aims EUS-FNA has suboptimal accuracy in diagnosing gastrointestinal subepithelial tumors (SETs). EUS-guided 22-gauge fine needle biopsy (EUS-FNB) and single-incision with needle knife (SINK) were proposed to increase accuracy of diagnosis. This study aimed to prospectively compare the diagnostic accuracy and safety of EUS-FNB with SINK in patients with upper gastrointestinal SETs.

Patients and methods All adult patients referred for EUS evaluation of upper gastrointestinal SETs ≥ 15 mm in size were eligible for inclusion. Patients were randomized to undergo EUS-FNB or SINK. Lesions were sampled with a 22-gauge reverse beveled core needle in the EUS-FNB group and by a conventional needle-knife sphincterotome and biopsy forceps in the SINK group. Patients were blinded to the technique used. The primary outcome was diagnostic accuracy. Secondary outcomes included adverse events, histological yield and procedure duration. Study enrollment was terminated early due to poor recruitment.

Results A total of 56 patients (31 male (55.37 %); mean age, 67.41 ± 12.70 years) were randomized to either EUS-FNB (n = 26) or SINK (n = 30). Technical success was 96.15 % and 96.66 %, respectively. The majority of lesions were gastrointestinal stromal tumors (51.78 %). No significant difference was found between EUS-FNB and SINK in terms of diagnostic accuracy for a malignant or benign disease (76 % vs. 89.28 %, respectively; P = 0.278). The rate of adverse events (none severe) was also comparable (7.69 % vs. 10 %, respectively; P = 1.0) including two abdominal pain episodes in the EUS-FNB group compared to two delayed bleeding (one requiring hospitalization and radiologic embolization) and 1 abdominal pain in the SINK group.

Conclusion EUS-FNB and SINK are equally effective techniques for upper gastrointestinal SETs sampling. SINK can be associated with mild to moderate delayed bleeding.

^* Drs. Sanaei and Fernández-Esparrach contributed equally.

• References

• 1 Dumonceau J-M, Deprez PH, Jenssen C. et al. Indications, results, and Clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – Updated January 2017. Endoscopy 2017; 49: 605-714
• 2 Akahoshi KSY, Matsui N. et al. Preoperative diagnosis of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needleaspiration. World J Gastroenterol 2007; 13: 2077-82
• 3 Lai EC, Lau SH, Lau WY. Current management of gastrointestinal stromal tumors-a comprehensive review. Int J Surg 2012; 10: 334-340
• 4 Zhang X-C, Li Q-L, Yu Y-F. et al. Diagnostic efficacy of endoscopic ultrasound-guided needle sampling for upper gastrointestinal subepithelial lesions: a meta-analysis. Surg Endosc 2016; 30: 2431-2441
• 5 Fernández-Esparrach G, Sendino O, Solé M. et al. Endoscopic ultrasound-guided fine-needle aspiration and trucut biopsy in the diagnosis of gastric stromal tumors: a randomized crossover study. Endoscopy 2010; 42: 292-299
• 6 Schlag C, Menzel C, Götzberger M. et al. Endoscopic ultrasound-guided tissue sampling of small subepithelial tumors of the upper gastrointestinal tract with a 22-gauge core biopsy needle. Endosc Int Open 2017; 5: E165-E171
• 7 Lee M, Min BH, Lee H. et al. Feasibility and diagnostic yield of endoscopic ultrasonography-guided fine needle biopsy with a new core biopsy needle device in patients with gastric subepithelial tumors. Medicine (Baltimore) 2015; 94: e1622
• 8 Lee JH, Cho CJ, Park YS. et al. EUS-guided 22-gauge fine needle biopsy for the diagnosis of gastric subepithelial tumors larger than 2 cm. Scand J Gastroenterol 2016; 51: 486-493
• 9 Han JP, Lee TH, Hong SJ. et al. EUS-guided FNA and FNB after on-site cytologic evaluation in gastric subepithelial tumors. J Dig Dis 2016; 17: 582-587
• 10 de la Serna-Higuera C, Pérez-Miranda M, Díez-Redondo P. et al. EUS-guided single-incision needle-knife biopsy: description and results of a new method for tissue sampling of subepithelial gastrointestinal tumors (with video). Gastrointest Endosc 2011; 74: 672-676
• 11 Kim JS, Kim BW, Kim GJ. et al. Diagnostic yield of endoscopic ultrasonography-guided single-incision needle knife biopsy for gastric subepithelial tumors: comparison with resected specimens. Surg Endosc 2016; 30: 5304-5309
• 12 Shimamura Y, Hwang J, Cirocco M. et al. Efficacy of single-incision needle-knife biopsy for sampling subepithelial lesions. Endosc Int Open 2017; 5: E5-E10
• 13 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
• 14 Vazquez-Sequeiros E, Wiersema MJ, Clain JE. et al. Impact of lymph node staging on therapy of esophageal cancer. Gastroenterology 2003; 125: 1626-1635
• 15 Chang KJ. State of the art lecture: endoscopic ulñtrasonography (EUS) and FNA in pancreatico-biliary tumors. Endoscopy 2006; 38: 556-560
• 16 Wallace MB, Pascual JM, Raimondo M. et al. Minimally invasive endoscopic staging of suspected lung cancer. JAMA 2008; 299: 540-546
• 17 El Chafic AH, Loren D, Siddiqui A. et al. Comparison of FNA and fine-needle biopsy for EUS-guided sampling of suspected gastrointestinal stromal tumors. Gastrointest Endosc 2017; 86: 510-515
• 18 Iwai T, Kida M, Imaizumi H. et al. Randomized crossover trial comparing EUS-guided fine-needle aspiration with EUS-guided fine-needle biopsy for gastric subepithelial tumors. Diagn Cytopathol 2018; 46: 228-233
• 19 Kim GH, Cho YK, Kim EY. et al. 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
• 20 Hamada T, Yasunaga H, Nakai Y. et al. Rarity of severe bleeding and perforation in endoscopic ultrasound-guided fine needle aspiration for submucosal tumors. Dig Dis Sci 2013; 58: 2634-2638
• 21 Ginès A, Wiersema MJ, Clain JE. et al. Prospective study of a Trucut needle for performing EUS-guided biopsy with EUS-guided FNA rescue. Gastrointest Endosc 2005; 62: 597-601
• 22 Saftoiu A, Vilmann P, Skov BG. et al. Endoscopic ultrasound (EUS)-guided Trucut biopsy adds significant information to EUS-guided fine-needle aspiration in selected patiens: a prospective study. Scand J Gastroenterol 2007; 42: 117-125
• 23 Wittmann J, Kocjan G, Sgouros SN. et al. Endoscopic ultrasound-guided tissue sampling by combined fine needle aspiration and trucut needle biopsy: a prospective study. Cytopathology 2006; 17: 27-33
• 24 Trindade AJ, Benias PC, Alshelleh M. et al. Fine-needle biopsy is superior to fine-needle aspiration of suspected gastrointestinal stromal tumors: a large multicenter study. Endosc Int Open 2019; 7: E931-E936
• 25 Asokkumar R, Yung KaC, Loh T. Comparison of tissue and molecular yield between fine-needle biopsy (FNB) and fine-needle aspiration (FNA): a randomized study. Endosc Int Open 2019; 7: E955-E963