Interventional EUS Using a Flexible 19-Gauge Needle: An International Multicenter Experience in 162 Patients

Kumbhari, Vivek; Peñas, I; Tieu, Alan H.; Serna-Higuera, Carlos de la; Juneja, Manie; Maufa, Fuad; Ngamruengphong, Saowanee; El-Zein, Mohamad H.; Haddad, Nadim; Krishnan, Sandeep; Gonzalez, Susana; Renny, Peter V.; Saxena, Payal; Howard, Linda; DiMaio, Christopher J.; Buscaglia, Jonathan M.; Pérez-Miranda, Manuel; Khashab, Mouen A.

doi:10.1007/s10620-016-4327-7

Cited by 12 publications

(10 citation statements)

References 27 publications

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“…In addition, this group used ROSE to improve the diagnostic yield of the procedure. More recent studies have also used the single-arm design, which biopsied a variety of lesions adjacent to the gastrointestinal wall 8,10,12 ; technical success rates were reported to be over 90% in all studies, similar to the results of our study. To compare the diagnostic yield with a regular stainless steel 19-G needle we obtained the histological samples in a random order using both the stainless steel and nitinol-based needles.…”

Section: Discussionsupporting

confidence: 87%

“…However, to the best of our knowledge all published studies are of a single-arm design and thus did not present a direct comparison between the two needle types. [8][9][10][11][12] In this prospective, multicenter, single-blinded, randomized trial we aimed to compare the diagnostic yield of a 19-G stainless steel EUS-FNB needle and a 19-G nitinol needle in regard of the histological diagnosis of a solid pancreatic mass as a primary endpoint. Secondary endpoints included diagnostic yield subdivided by puncture route as well as diagnostic accuracy depending on the order of the needles, time spent on puncture, technical failure rate and histological amount obtained.…”

Section: Introductionmentioning

confidence: 99%

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Multicenter, randomized comparison of the diagnostic accuracy of 19‐gauge stainless steel and nitinol‐based needles for endoscopic ultrasound‐guided fine‐needle biopsy of solid pancreatic masses

et al. 2020

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Background The use of 19-gauge (G) stainless steel needles for endoscopic ultrasound-guided fine-needle biopsy of a pancreatic mass often results in technical difficulties due to an inability to advance the relatively rigid needle out of the endoscope. More flexible nitinol-based needles might decrease such technical difficulties and thus increase diagnostic accuracy. Objective In this prospective multicenter randomized single-blinded study we compared the diagnostic value of those two needle types in patients with a solid pancreatic lesion. Methods Patients with a solid pancreatic mass were diagnosed with endoscopic ultrasound-guided fine-needle biopsy using one puncture with each needle in a randomized fashion. The primary endpoint was the diagnostic accuracy of each needle. Secondary endpoints included time for puncture, amount of tumour tissue obtained, and technical failure. Histological specimens were centrally reviewed by a pathologist blinded to the final needle type and final diagnosis (ClinicalTrials.gov Identifier: NCT02909530). Results Out of 46 prospectively recruited patients, central pathological examination was available for 41. Diagnostic accuracy for the two needles combined was 87.8%. Diagnostic accuracy was 66% and 68% using the stainless steel- and nitinol-based needle respectively. Time spent for puncturing was 137 ± 61 s (mean ± standard deviation) for the stainless steel and 111 ± 53 s for the nitinol-based needle ( p = 0.037). Technical failure occurred in three (6.5%) cases using the stainless steel- and in none using the nitinol-based needle. Conclusions Usage of a nitinol-based 19-G needle failed to present a significant superior accuracy compared with a stainless steel needle in endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions.

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Multicenter, randomized comparison of the diagnostic accuracy of 19‐gauge stainless steel and nitinol‐based needles for endoscopic ultrasound‐guided fine‐needle biopsy of solid pancreatic masses

et al. 2020

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“…Apart from these, a study focusing on the interventional capabilities of the 19-gauge flexible needle, though without a comparator, demonstrated equivalent safety, technical and clinical success in the straight versus the angulated endoscope position patient cohorts. [ 31 ] In fact, based on these results of the study by Varadarajulu et al . mentioned above,[ 24 ] and a subsequent study by Bang et al .,[ 32 ] an algorithm has been developed in which the flex needle was recommended for sampling lesions through the duodenum when a tissue core biopsy specimen is required, especially in institutions with no availability of ROSE.…”

Section: Discussionmentioning

confidence: 90%

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

et al. 2017

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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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“…FNA showed a very high feasibility (98%) and diagnostic accuracy (93%); however, the authors excluded lesions localized in the head or uncinate process of the pancreas to avoid the transduodenal route and its complications. More recently, Varadarajulu et al 20 and Kumbhari et al 21 described their experience with the 19-G needles from Boston Scientific, highlighting the usefulness of the needles in the safe sampling of lesions from all different GI sites independently from the scope position.…”

Section: Discussionmentioning

confidence: 99%

Feasibility and Accuracy of Transduodenal Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Solid Lesions Using a 19-Gauge Flexible Needle: A Multicenter Study

Nucci¹,

Petrone

Imperatore

et al. 2021

Clin Endosc

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INTRODUCTION Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a safe, simple, and accurate method for correctly diagnosing pancreatic lesions, gastrointestinal (GI) submucosal lesions, and abdominal and thoracic lymph node metastases. When performed by trained cytopathologists, its results are reliable, 1 with a diagnostic yield of approximately of 90%-95% and an overall sensitivity and specificity of 90% and 100%, respectively. 2 However, the diagnostic sensitivity is high only when rapid on-site evaluation (ROSE) of specimens is performed to assess their adequacy. 3,4 Most institutions do not have skilled pathologists available to perform ROSE. Moreover, EUS-FNA may not be totally effective because it provides cells that have been largely disrupted from their original arrangement and thus difficult to interpret. 5 Meanwhile, fine-needle biopsy (FNB) provides core tissue with better preservation of the cellular architecture and is likely to offer

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Interventional EUS Using a Flexible 19-Gauge Needle: An International Multicenter Experience in 162 Patients

Abstract: This study demonstrates equivalent technical success, clinical success and safety of using a flexible 19-G needle in straight and angulated endoscope positions for interventional EUS. Therefore, a flexible needle may be considered where an angulated echoendoscope position is encountered.

Cited by 12 publications

References 27 publications

Multicenter, randomized comparison of the diagnostic accuracy of 19‐gauge stainless steel and nitinol‐based needles for endoscopic ultrasound‐guided fine‐needle biopsy of solid pancreatic masses

Multicenter, randomized comparison of the diagnostic accuracy of 19‐gauge stainless steel and nitinol‐based needles for endoscopic ultrasound‐guided fine‐needle biopsy of solid pancreatic masses

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

Feasibility and Accuracy of Transduodenal Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Solid Lesions Using a 19-Gauge Flexible Needle: A Multicenter Study

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