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A prospective randomized study of the difference in diagnostic yield between endoscopic ultrasound-guided fine-needle aspiration (EUSFNA) needles with and without a side port in pancreatic masses.

ABSTRACT: BACKGROUND AND STUDY AIMS:Two 22G needles with similar designs, apart from the absence (A) or presence of a side port (B), are available for endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA). The side port was designed to increase diagnostic yield but this advantage was unproven. This study evaluated the difference in diagnostic yield between both needles in pancreatic masses. PATIENTS AND METHODS:This was a prospective multicenter randomized cross-over study. Patients with pancreatic masses were randomized to one needle for the first two passes, followed by the other for the next two passes. A pathologist blinded to the needle assessed each puncture for cellularity and morphology. The diagnostic yield between both needles was compared. RESULTS:In total, 30 patients were recruited (mean lesion size: 3.5?cm, range: 1.2?-?6.3). Comparison of cellularity adequacy: first pass: A vs. B: 26/30 vs. 24/30 (P?=?0.488): 2nd pass: A vs. B: 25/30 vs. 26/30 (P?=?0.718). Comparison of diagnostic accuracy: first pass: A vs. B: 22/30 vs. 23/30 (P?=?0.766); after two passes: A vs. B: 26/30 vs. 26/30 (P?=?1.0). When all four passes were assessed, adequate cellularity was obtained in 29/30 and the correct diagnosis was obtained in 28/30 patients. There were no procedural complications. CONCLUSIONS:There was no significant difference in diagnostic yield between EUSFNA needles with or without a side port for pancreatic masses. STUDY REGISTRATION:NCT02092519.

SUBMITTER: Ang TL

PROVIDER: S-EPMC4554507 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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A prospective randomized study of the difference in diagnostic yield between endoscopic ultrasound-guided fine-needle aspiration (EUSFNA) needles with and without a side port in pancreatic masses.

Ang Tiing Leong TL Kwek Andrew Boon Eu AB Seo Dong Wan DW Paik Woo Hyun WH Cheng Tsu-Yao TY Wang Hsiu-Po HP Lau James J

Endoscopy international open 20150526 4

<h4>Background and study aims</h4>Two 22G needles with similar designs, apart from the absence (A) or presence of a side port (B), are available for endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA). The side port was designed to increase diagnostic yield but this advantage was unproven. This study evaluated the difference in diagnostic yield between both needles in pancreatic masses.<h4>Patients and methods</h4>This was a prospective multicenter randomized cross-over study. Patien ...[more]

PMID: 26356802

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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: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

A prospective randomized study of the difference in diagnostic yield between endoscopic ultrasound-guided fine-needle aspiration (EUSFNA) needles with and without a side port in pancreatic masses.

Publications

A prospective randomized study of the difference in diagnostic yield between endoscopic ultrasound-guided fine-needle aspiration (EUSFNA) needles with and without a side port in pancreatic masses.

Similar Datasets

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