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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.

ABSTRACT: 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.

SUBMITTER: Hann A

PROVIDER: S-EPMC7184661 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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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.

Hann Alexander A Epp Sonja S Veits Lothar L Rosien Ulrich U Siegel Julian J Möschler Oliver O Bohle Wolfram W Meining Alexander A

United European gastroenterology journal 20191107 3

<h4>Background</h4>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.<h4>Objective</h4>In this prospective multicenter randomized single-blinded study we compared the diagnostic value of thos ...[more]

PMID: 32213013

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Project description:Background and study aims ?Endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) is traditionally considered a first-line strategy for diagnosing pancreatic lesions; however, given less than ideal accuracy rates, fine-needle biopsy (FNB) has been recently developed to yield histological tissue. The aim of this study was to compare diagnostic yield and safety between EUS-FNA and EUS-FNB in sampling of pancreatic masses. Patients and methods ?This was a multicenter retrospective study to evaluate efficacy and safety of EUS-FNA and EUS-FNB for pancreatic lesions. Baseline characteristics including sensitivity, specificity, and accuracy, were evaluated. Rapid on-site evaluation (ROSE) diagnostic adequacy, cell-block accuracy, and adverse events were analyzed. Subgroup analyses comparing FNA versus FNB route of tissue acquisition and comparison between methods with or without ROSE were performed. Multivariable logistic regression was also performed. Results ?A total of 574 patients (n?=?194 FNA, n?=?380 FNB) were included. Overall sensitivity, specificity, and accuracy of FNB versus FNA were similar [(89.09?% versus 85.62?%; P ?=?0.229), (98.04?% versus 96.88?%; P ?=?0.387), and 90.29?% versus 87.50?%; P ?=?0.307)]. Number of passes for ROSE adequacy and cell-block accuracy were comparable for FNA versus FNB [(3.06?±?1.62 versus 3.04?±?1.88; P ?=?0.11) and (3.08?±?1.63 versus 3.35?±?2.02; P ?=?0.137)]. FNA?+?ROSE was superior to FNA alone regarding sensitivity and accuracy [91.96?% versus 70.83?%; P ?<?0.001) and (91.80?% versus 80.28?%; P ?=?0.020)]. Sensitivity of FNB?+?ROSE and FNB alone were superior to FNA alone [(92.17?% versus 70.83?%; P ?<?0.001) and (87.44?% versus 70.83?%; P ?<?0.001)]. There was no difference in sensitivity though improved accuracy between FNA?+?ROSE versus FNB alone [(91.96?% versus 87.44?%; P ?=?0.193) and (91.80?% versus 80.72?%; P ?=?0.006)]. FNB?+?ROSE was more accurate than FNA?+?ROSE (93.13?% versus 91.80?% ; P ?=?0.001). Multivariate analysis showed ROSE was a significant predictor of accuracy [OR 2.60 (95?% CI, 1.41-4.79)]. One adverse event occurred after FNB resulting in patient death. Conclusion ?EUS-FNB allowed for more consistent cell-block evaluation as compared to EUS-FNA. EUS-FNA?+?ROSE was found to have a similar sensitivity to EUS-FNB alone suggesting a reduced need for ROSE as part of the standard algorithm of pancreatic sampling. While FNB alone produced similar diagnostic findings to EUS-FNA?+?ROSE, FNB?+?ROSE still was noted to increase diagnostic yield. This finding may favor a unique role for FNB?+?ROSE, suggesting it may be useful in cases when previous EUS-guided sampling may have been indeterminate.

Project description:Background and Objectives: Endoscopic ultrasound (EUS) fine needle biopsy (FNB) needles were designed to improve histologic yield, while maintaining the flexibility to permit ease of use. However, the diagnostic benefit of EUS-FNB needles as compared to the conventional fine needle aspiration (FNA) needles remains unclear. This study aimed to identify the diagnostic accuracy of combined needle use of a new 20-gauge ProCore FNB needle and a 25-gauge FNA needle. Methods: For this study, cases were selected in which both the 20-gauge ProCore FNB needle and the 25-gauge FNA needle were used during a single EUS procedure for sampling of a solid pancreatic mass, lymph node, or submucosal mass. Tissue acquisition was performed in the course of the ASPRO trial, a multicenter randomized study comparing the diagnostic value of 20-gauge ProCore FNB and 25-gauge FNA needles (ClinicalTrials.gov: NCT02167074). The protocol allowed additional sampling with the nonassigned needle, at the discretion of an endosonographer. Results: Of all 615 patients who were randomized for the ASPRO study, 74 were sampled with both needle types. In these combined needle cases, FNA was used first in 24 and ProCore FNB in 50 cases. Target lesions encompassed 39 solid pancreatic lesions, 18 submucosal masses, and 17 lymph nodes. Most pancreatic lesions were located in the head (25/39), lymph nodes were mainly located in the abdomen (15/18), and submucosal lesions were located in the stomach (8/20), esophagus (4/20), small intestines (3/20), and rectum (3/20). The main reason to use ProCore in addition to FNA was to collect more tissue for ancillary testing (79%). FNA was generally used in addition to ProCore to allow for on-site pathological assessment (76%). The regimen of FNA followed by ProCore resulted in 100% accuracy, while for ProCore followed by FNA, 88% was reached (P = 0.086). The type of target lesion, either pancreatic or nonpancreatic, did not affect the diagnostic accuracy of the two sampling regimens (odds ratio 1.2, 95% confidence interval 0.22–6.61, P = 0.834). Conclusion: FNA followed by ProCore FNB provides for a 100% diagnostic accuracy and tends to outperform ProCore FNB followed by FNA. Accuracy rates were independent of the type of target lesion.

Project description:ObjectiveTo evaluate the feasibility and diagnostic performance of ultrasound (US)-guided fine-needle aspiration cytology and core-needle biopsy (US-FNAC/CNB) for the diagnosis of laryngo-hypopharyngeal masses.Materials and methodsThis was a single-center prospective case series. From January 2018 to June 2019, we initially enrolled 40 patients with highly suspicious laryngo-hypopharyngeal masses on laryngoscopic examinations. Of these, 28 patients with the mass involving or abutting the pre-epiglottic, paraglottic, pyriform sinus, and/or subglottic regions were finally included. These patients underwent US examinations with/without subsequent US-FNAC/CNB under local anesthesia for evaluation of the laryngo-hypopharyngeal mass.ResultsOf the 28 patients who underwent US examinations, a laryngo-hypopharyngeal mass was identified in 26 patients (92.9%). US-FNAC/CNB was performed successfully in 25 of these patients (96.2%), while the procedure failed to target the mass in 1 patient (3.8%). The performance of US caused minor subclinical hematoma in 2 patients (7.7%), but no major complications occurred. US-FNAC/CNB yielded conclusive results in 24 (96.0%) out of the 25 patients with a successful procedure, including 23 patients with squamous cell carcinoma (SCC) and 1 patient with a benign mass. In one patient with atypical cells in US-FNAC, additional direct laryngoscopic biopsy (DLB) was required to confirm SCC. Among the 26 patients who received US-FNAC/CNB, the time from first visit to pathological diagnosis was 7.8 days. For 24 patients finally diagnosed with SCC, the time from first visit to the initiation of treatment was 25.2 days. The mean costs associated with US-FNAC/CNB was $272 under the Korean National Health Insurance Service System.ConclusionUS-FNAC/CNB for a laryngo-hypopharyngeal mass is technically feasible in selected patients, providing good diagnostic performance. This technique could be used as a first-line diagnostic modality by adopting appropriate indications to avoid general anesthesia and DLB-related complications.

Dataset Information

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.

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.

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