scholarly journals EUS-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid on-site evaluation of cytopathology in pancreatic lesions: a multicenter randomized trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Yen-I Chen ◽  
Avijit Chatterjee ◽  
Robert Berger ◽  
Yonca Kanber ◽  
Jonathan M Wyse ◽  
...  

Background and Study Aims: EUS-guided fine needle aspiration (EUS-FNA) is the standard in the diagnosis of pancreatic solid lesions, in particular when combined with rapid on-site evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone; however, has not been compared to EUS-FNA+ROSE in a large clinical trial. Our aim is to compare EUS-FNB alone to EUS-FNA+ROSE in solid pancreatic lesions. Patients and Methods: Multicenter non-inferiority RCT involving 7 centers. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary endpoint is diagnostic accuracy. Secondary endpoints include sensitivity/specificity, mean number of needle passes, and cost. Results: 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA+ROSE. Overall, 217 patients had a malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA+ROSE 92.2% (95% CI: 86.6-96.9%) and 93.3% (95% CI: 88.8-97.9%), respectively p=0.72. Diagnostic sensitivity for malignancy was 92.5% (95% CI: 85.7-96.7%) EUS-FNB alone vs. 96.5% (93.0-98.6%) EUS-FNA+ROSE (p=0.46) while specificity was 100% in both. Adequate histology yield was obtained in 87.5% of the EUS-FNB alone samples. Mean number of needle of passes and procedure time favored EUS-FNB alone (2.3±0.6 passes vs. 3.0±1.1 passes p≤0.01 and 19.3±8.0 minutes vs. 22.7±10.8 minutes p <0.01). EUS-FNB alone cost on average 45USD more than EUS-FNA+ROSE. Conclusion: EUS-FNB alone is non-inferior to EUS-FNA+ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost. (clinicaltrials.gov: NCT03435588).

2020 ◽  
Vol 08 (06) ◽  
pp. E738-E747 ◽  
Author(s):  
Diogo T.H. de Moura ◽  
Thomas R. McCarty ◽  
Pichamol Jirapinyo ◽  
Igor B. Ribeiro ◽  
Kelly E. Hathorn ◽  
...  

Abstract 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.


2021 ◽  
Vol 09 (06) ◽  
pp. E901-E906
Author(s):  
Benedetto Mangiavillano ◽  
Leonardo Frazzoni ◽  
Thomas Togliani ◽  
Carlo Fabbri ◽  
Ilaria Tarantino ◽  
...  

Abstract Background and study aims The standard method for obtaining samples during endoscopic ultrasonography (EUS) is fine-needle aspiration (FNA), the accuracy of which can be affected by the presence of a cytopathologist in endoscopy room (rapid on-site evaluation [ROSE]). With the introduction of fine-needle biopsy (FNB), macroscopic on-site evaluation (MOSE) of a acquired specimen has been proposed. Only a few studies have evaluated the role of MOSE and in all except one, a 19G needle was used. Our primary aim was to evaluate the diagnostic yield and accuracy of MOSE with different needle sizes and the secondary aim was to identify factors influencing the yield of MOSE. Patients and methods Data from patients who underwent EUS-FNB for solid lesions, with MOSE evaluation of the specimen, were collected in six endoscopic referral centers. Results A total of 378 patients (145 F and 233 M) were enrolled. Needles sizes used during the procedures were 20G (42 %), 22G (45 %), and 25G (13 %). The median number of needle passes was two (IQR 2–3). The overall diagnostic yield of MOSE was of 90 % (confidence interval [CI] 86 %–92 %). On multivariable logistic regression analysis, variables independently associated with the diagnostic yield of MOSE were a larger needle diameter (20G vs. 25G, OR 11.64, 95 %CI 3.5–38.71; 22G vs. 25G, OR 6.20, 95 %CI 2.41–15.90) and three of more needle passes (OR 3.39, 95 %CI 1.38–8.31). Conclusions MOSE showed high diagnostic yield and accuracy. Its yield was further increased if performed with a large size FNB needles and more than two passes.


2020 ◽  
Vol 8 (5) ◽  
pp. 349-354
Author(s):  
Lindsey M Temnykh ◽  
Mahmoud A Rahal ◽  
Zahra Zia ◽  
Mohammad A Al-Haddad

Abstract Background Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is increasingly utilized to enhance the cytological yield of sampling solid lesions, but its superiority over existing fine-needle aspiration (FNA) platforms has not been clearly demonstrated. The aim of our study was to compare the diagnostic accuracy and procedural outcomes of FNB using a new Franseen-tip needle to that of a traditional FNA in sampling solid lesions under EUS guidance. Methods Consecutive patients with solid lesions referred for EUS-FNB sampling were included. Procedure-related outcomes were collected prospectively including patient demographics, number of passes performed, diagnostic sample adequacy, adverse events, and recovery time. The Acquire needle was used to sample all lesions in the study group. Consecutive EUS-FNA procedures performed to sample solid lesions using the Expect needle were utilized as controls. Results There were 180 patients undergoing EUS-FNB compared to 183 patients undergoing EUS-FNA procedures for solid-lesion sampling. The procedure time was significantly shorter in patients who underwent FNB compared to FNA (mean: 37.4 vs 44.9 minutes, P &lt; 0.001). Significantly fewer passes were performed in the FNB cohort compared to the FNA group (mean: 2.9 vs 3.8, P &lt; 0.001). The cytologic diagnostic yield was significantly higher in the FNB group compared to the FNA group (98.3% vs 90.2%, P = 0.003). No significant difference in the incidence of adverse events was observed between the FNB and FNA groups (1.1% vs 0.5%, P = 0.564). Conclusions An FNB-exclusive approach to sampling solid lesions under EUS guidance is safe and feasible, and may result in fewer overall passes, shorter procedure time, and improved diagnostic adequacy. FNB may replace FNA as the primary sampling modality of choice in all solid lesions.


2020 ◽  
Vol 08 (02) ◽  
pp. E155-E162 ◽  
Author(s):  
Priscilla A. van Riet ◽  
Rutger Quispel ◽  
Djuna L. Cahen ◽  
Mieke C. Snijders-Kruisbergen ◽  
Petri van Loenen ◽  
...  

Abstract Background and study aims The traditional “smear technique” for processing and assessing endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is sensitive to artifacts. Processing and evaluation of specimens collected in a liquid medium, liquid-based cytology (LBC) may be a solution. We compared the diagnostic value of EUS-FNA smears to LBC in pancreatic solid lesions in the absence of rapid on-site evaluation (ROSE). Patients and methods Consecutive patients who required EUS-FNA of a solid pancreatic lesion were included in seven hospitals in the Netherlands and followed for at least 12 months. Specimens from the first pass were split into two smears and a vial for LBC (using ThinPrep and/or Cell block). Smear and LBC were compared in terms of diagnostic accuracy for malignancy, sample quality, and diagnostic agreement between three cytopathologists. Results Diagnostic accuracy for malignancy was higher for LBC (82 % (58/71)) than for smear (66 % (47/71), P = 0.04), but did not differ when smears were compared to ThinPrep (71 % (30/42), P = 0.56) or Cell block (62 % (39/63), P = 0.61) individually. Artifacts were less often present in ThinPrep (57 % (24/42), P = 0.02) or Cell block samples (40 % (25/63), P < 0.001) than smears (76 % (54/71)). Agreement on malignancy was equally good for smears and LBC (ĸ = 0.71 versus ĸ = 0.70, P = 0.98), but lower for ThinPrep (ĸ = 0.26, P = 0.01) than smears. Conclusion After a single pass, LBC provides higher diagnostic accuracy than the conventional smear technique for EUS-FNA of solid pancreatic lesions in the absence of ROSE. Therefore, LBC, may be an alternative to the conventional smear technique, especially in centers lacking ROSE.


2020 ◽  
Vol 7 (7) ◽  
pp. A366-374
Author(s):  
Vaishali Baburao Nagose ◽  
Shruthi Amit Deshpande ◽  
Dinesh Kasturi ◽  
Varsha Ashok Jadhav

Background: The various advantages of Fine-needle aspiration (FNA) biopsy/ cytology can be limited due to inadequacy of the specimen and expertise required for diagnosis. Cell blocks (CBs), though routinely used in cytology of body fluids, can also be used in FNA material with considerable increase in diagnostic accuracy. Aims & objectives: To compared FNA & CB as diagnostic tool and to evaluate whether cell block adds to the diagnostic accuracy of FNA. Methods: This is a two years prospective study carried out in the pathology department of a tertiary heath care hospital and medical college of South India which included the cases undergoing the FNAC, and followed by the biopsy. CB was prepared using Tissue coagulum clot (TCC) method. The smears and tissue sections were assessed for cellularity and adequacy for diagnosis. CBs were grouped into four diagnostic categories. FNA & CB were compared with histopathology (HPE) diagnosis to calculate Sensitivity, Specificity and Diagnostic Accuracy. Result: A total of 195 cases were included. Cellularity and adequacy for diagnosis were higher in CB. They were diagnostically better (superior) in 13.84% (27) cases. The sensitivity (95.77%) and diagnostic accuracy (94.87%) of CB was found to be considerably higher than FNA (78.84% and 78.46% respectively). Conclusion: In cases of suspicious/ intermediate diagnosis or diagnosis discordant with clinical ones, by FNA; should be followed with the CB to improve the diagnostic yield & to facilitate accurate diagnoses. TCC method is a simple CB method which has higher diagnostic accuracy than FNA.


1970 ◽  
Vol 1 (2) ◽  
pp. 108-113 ◽  
Author(s):  
S Vaidya ◽  
A Sinha ◽  
S Narayan ◽  
S Adhikari ◽  
KC Sabira

Background: A wide variety of benign and malignant tumours originate in the salivary glands and insufficient tumour cells make their diagnosis difficult in some patients. The aim of this study was to evaluate the efficacy of fine-needle aspiration cytology in the diagnosis of salivary gland lesions and to correlate cytological findings with histopathology. Materials and Methods: This was a prospective study done from September 2002 to May 2004. Fine needle aspiration cytology was performed in 58 patients with clinically significant salivary gland masses. Results: Fine needle aspiration cytology categorized 67.24% of the salivary gland lesions as neoplastic and 32.76% as non-neoplastic lesions. Amongst the neoplastic lesions, 76.9% were benign and 23.1% were malignant cases. Histopathological examination revealed that 81.05% of the cases were benign and 18.95% were malignant. Fine needle aspiration cytology had a sensitivity, specificity and diagnostic accuracy of 81.82%, 100% and 96.55%, respectively. The positive predictive value and negative predictive value was 100% and 95.9%, respectively. Conclusion: Fine needle aspiration of the salivary gland is a safe and reliable technique in the primary diagnosis of salivary gland lesions. Although, limitations are encountered while predicting specific lesions on cytology, especially when dealing with cystic and some malignant lesions, this study has shown that fine needle aspiration cytology has a high sensitivity, specificity and diagnostic accuracy in diagnosing salivary gland lesions. Keywords: Salivary glands; Fine needle aspiration cytology; Histopathology DOI: http://dx.doi.org/10.3126/jpn.v1i2.5403 JPN 2011; 1(2): 108-113


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