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

Abstract

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.

High diagnostic adequacy and accuracy of the new 20G procore needle for EUS-guided tissue acquisition: Results of a large multicentre retrospective study

“…[2325] This suggestion has been questioned by the results of a recently published multicenter international prospective study in which 246 patients with solid lesions (203 cases) or enlarged lymph nodes who needed to undergo EUS sampling only from the duodenum were analyzed. [21] Main outcomes such as diagnostic adequacy and accuracy significantly varied across centers, despite only high volume centers were included, and the procedures were performed by recognized experts in EUS-FNB. In addition, major complications were reported in six cases (two bleeding cases, two acute pancreatitis, one perforation requiring surgery, and one duodenal hematoma).…”

“…However, the performance of flexible 19G needles seems still suboptimal for obtaining transduodenal tissue suitable for histological examination reporting an overall diagnostic accuracy of only 73.6%. [21]…”

Medical Diagnostic Tests: A Review of Test Anatomy, Phases, and Statistical Treatment of Data

“…The NND and NNM are less frequently reported in the evaluation of the accuracy of a diagnostic test. Several examples identified in the available scientific literature are as follows: color duplex ultrasound in the diagnosis of carotid stenosis [180], culture-based diagnosis of tuberculosis [181], prostate-specific antigen [182, 183], endoscopic ultrasound-guided fine needle biopsy with 19-gauge flexible needle [184], number needed to screen-prostate cancer [185, 186], the integrated positron emission tomography/magnetic resonance imaging (PET/MRI) for segmental detection/localization of prostate cancer [187], serum malondialdehyde in the evaluation of exposure to chromium [188], the performances of the matrix metalloproteinase-7 (MMP-7) in the diagnosis of epithelial injury and of biliary atresia [189], lactate as a diagnostic marker of pleural and abdominal exudate [190], the Gram stain from a joint aspiration in the diagnosis of pediatric septic arthritis [191], and performances of a sepsis algorithm in an emergency department [192]. Unfortunately, the NND or NNM point estimators are not all the time reported with the associated 95% confidence intervals [161, 180, 181, 186, 187, 190, 191].…”

Endoscopic ultrasound-guided sampling of solid pancreatic masses: the fine needle aspiration or fine needle biopsy dilemma. Is the best needle yet to come?

“…Moreover, using the 19 G needle could be difficult when sampling pancreatic masses with the scope in the duodenum because of its stiffness and caliber, which could affect the needle flexibility and its diagnostic yield. In a large multicenter prospective study from Attili et al[49], 246 patients with solid lesions (203 cases) or enlarged lymph nodes (43 cases) were examined. The procedure was technically feasible in 228 patients, with an overall procurement yield of 76.8%, which was very low.…”

“…ROSE was available only in some of them[4,58], and they used stylet or suction method[50]. No difference was found in the accuracy of final diagnosis in all studies, but the sample histological quality was higher for reverse bevel than for FNA needles[49,56]. Lee et al[58] found a higher accuracy for samples obtained with reverse bevel needles during the ROSE.…”