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A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy.

ABSTRACT: Techniques to optimize endoscopic ultrasound-guided tissue acquisition (EUS-TA) in a variety of lesion types have not yet been established. The primary aim of this study was to compare the diagnostic yield (DY) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for pancreatic and non-pancreatic masses.Consecutive patients referred for EUS-TA underwent randomization to EUS-FNA or EUS-FNB at four tertiary-care medical centers. A maximum of three passes were allowed for the initial method of EUS-TA and patients were crossed over to the other arm based on on-site specimen adequacy.A total of 140 patients were enrolled. The overall DY was significantly higher with specimens obtained by EUS-FNB compared to EUS-FNA (90.0 % vs. 67.1 %, P = 0.002). While there was no difference in the DY between the two groups for pancreatic masses (FNB: 91.7 % vs. FNA: 78.4 %, P = 0.19), the DY of EUS-FNB was higher than the EUS-FNA for non-pancreatic lesions (88.2 % vs. 54.5 %, P = 0.006). Specimen adequacy was higher for EUS-FNB compared to EUS-FNA for all lesions (P = 0.006). There was a significant rescue effect of crossover from failed FNA to FNB in 27 out of 28 cases (96.5 %, P = 0.0003). Decision analysis showed that the strategy of EUS-FNB was cost saving compared to EUS-FNA over a wide range of cost and outcome probabilities.RESULTS of this RCT and decision analysis demonstrate superior DY and specimen adequacy for solid mass lesions sampled by EUS-FNB.

SUBMITTER: Aadam AA

PROVIDER: S-EPMC4874800 | biostudies-other | 2016 May

REPOSITORIES: biostudies-other

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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.

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A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy.

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