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Year : 2017  |  Volume : 6  |  Issue : 6  |  Page : 402-408

Low diagnostic yield of transduodenal endoscopic ultrasound-guided fine needle biopsy using the 19-gauge Flex needle: A large multicenter prospective study

1 Digestive Endoscopy Unit, Catholic University, Rome, Italy
2 Unit of Gastroenterology and Digestive Endoscopy, AUSL Bologna Bellaria-Maggiore Hospital, Bologna, Italy
3 Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan
4 Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy
5 Department of Endoscopy, Trocadero Clinic, Paris, France
6 Department of Diagnostic and Therapeutic Services, Endoscopy Service, IRCCS-ISMETT, Palermo, Italy
7 Department of Gastroenterology, Indiana University Health Medical Center, Indianapolis, Indiana, USA
8 Digestive Endoscopy Unit, Catholic University, Rome, Italy; Department of Gastroenterology, Colentina Clinical Hospital; Department of Internal Medicine, Carol Davila University of Medicine, Bucharest, Romania, Romania

Correspondence Address:
Dr. Alberto Larghi
Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/eus.eus_54_17

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Background and Objectives: Previous limited experiences have reported the 19-gauge flexible needle to be highly effective in performing endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for transduodenal lesions. We designed a large multicenter prospective study with the aim at evaluating the performance of this newly developed needle. Patients and Methods: Consecutive patients with solid lesions who needed to undergo EUS sampling from the duodenum were enrolled in 6 tertiary care referral centers. Puncture of the lesion was performed with the 19-gauge flexible needle (Expect™ and Slimline Expect™ 19 Flex). The feasibility, procurement yield, and diagnostic accuracy were evaluated. Results: Totally, 246 patients (144 males, mean age 65.1 ± 12.7 years) with solid lesions (203 cases) or enlarged lymph nodes (43 cases) were enrolled, with a mean size of 32.6 ± 12.2 mm. The procedure was technically feasible in 228 patients, with an overall procurement yield of 76.8%. Two centers had suboptimal procurement yields (66.7% and 64.2%). Major complications occurred in six cases: two of bleeding, two of mild acute pancreatitis, one perforation requiring surgery, and one duodenal hematoma. Considering malignant versus nonmalignant disease, the sensitivity, specificity, positive/negative likelihood ratios, and diagnostic accuracy were 70.7% (95% confidence interval [CI]: 64.3–76.6), 100% (95% CI: 79.6–100), 35.3 (95% CI: 2.3–549.8)/0.3 (95% CI: 0.2–0.4), and 73.6% (95% CI: 67.6–79). On multivariate analysis, the only determinant of successful EUS-FNB was the center in which the procedure was performed. Conclusions: Our results suggest that the use of the 19-gauge flexible needle cannot be widely advocated and its implementation should receive local validation after careful evaluation of both the technical success rates and diagnostic yield.

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