Rapid on-site evaluation during endoscopic ultrasoundguided fine-needle aspiration of lymph nodes does not increase diagnostic yield: A randomized, multicenter trial

Kappelle, Wouter; Leerdam, Monique E. van; Schwartz, Matthijs P.; Bulbul, Mustafa G.; Buikhuisen, Wieneke A.; Brink, Menno A.; Sie-Go, Daisy M. D. S.; Pullens, Hendrikus J.M.; Nikolakopoulos, Stavros; Diest, P. J. van; Leenders, M.W.H.; Moons, Leon M.G.; Bogte, Auke; Siersema, Peter D.; Vleggaar, Frank P.

doi:10.1038/s41395-018-0025-8

Cited by 34 publications

(30 citation statements)

References 36 publications

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“…29 Severe adverse events are very rare. 6,23,30 In our study, similar to several studies that compared FNA and FNB, no adverse events were reported. 30,31 Currently, this is the largest study to exclusively evaluate EUS-guided LN sampling.…”

Section: Discussionsupporting

confidence: 86%

“…26,27 Specifically for LNs, a multicenter randomized controlled trial showed that the diagnostic yield and accuracy of EUS-FNA in mediastinal and abdominal LNs with or without ROSE were comparable. 23 However, the time required to review slides was shorter and post-procedural pain was less often reported in the ROSE group. In our study, ROSE was selectively utilized, usually in cases that were more challenging or had failed prior sampling.…”

Section: Discussionmentioning

confidence: 96%

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Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

et al. 2020

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Background/Aims: Endoscopic ultrasound fine-needle aspiration (EUS-FNA) is preferred for sampling of lymph nodes (LNs) adjacent to the gastrointestinal wall; however, fine-needle biopsy (FNB) may provide improved diagnostic outcomes. This study aimed to evaluate the comparative efficacy and safety of FNA versus FNB for LN sampling. Methods: This was a multicenter retrospective study of prospectively collected data to evaluate outcomes of EUS-FNA and EUS-FNB for LN sampling. Characteristics analyzed included sensitivity, specificity, accuracy, the number of needle passes, diagnostic adequacy of rapid on-site evaluation (ROSE), cell-block analysis, and adverse events. Results: A total of 209 patients underwent EUS-guided LN sampling. The mean lesion size was 16.22±8.03 mm, with similar sensitivity and accuracy between FNA and FNB ([67.21% vs. 75.00%, respectively, p=0.216] and [78.80% vs. 83.17%, respectively, p=0.423]). The specificity of FNB was better than that of FNA (100.00% vs. 93.62%, p=0.01). The number of passes required for diagnosis was not different. Abdominal and peri-hepatic LN location demonstrated FNB to have a higher sensitivity (81.08% vs. 64.71%, p=0.031 and 80.95% vs. 58.33%, p=0.023) and accuracy (88.14% vs. 75.29%, p=0.053 and 88.89% vs. 70.49%, p=0.038), respectively. ROSE was a significant predictor for accuracy (odds ratio, 5.16; 95% confidence interval, 1.15-23.08; p=0.032). No adverse events were reported in either cohort. Conclusions: Both EUS-FNA and EUS-FNB are safe for the diagnosis of LNs. EUS-FNB is preferred for abdominal LN sampling. EUS-FNA+ROSE was similar to EUS-FNB alone, showing better diagnosis for EUS-FNB than traditional FNA. While ROSE remained a significant predictor for accuracy, due to its poor availability in most centers, its use may be limited to cases with previous inconclusive diagnoses. Clin Endosc 2019 Dec 3. [Epub ahead of print]

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 96%

Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

et al. 2020

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“…A meta-analysis and systematic review by Kong et al showed that the use of ROSE did not improve the diagnostic yield and accuracy, nor did it improve the pooled sensitivity and specificity for EUS-FNA of pancreatic masses [22]. Similarly, a Dutch group studied the impact of ROSE during EUS-FNA of mediastinal and abdominal lymph nodes; the multicenter, randomized trial showed that EUS-FNA with and without ROSE were comparable in terms of diagnostic yield and accuracy [23]. When EUS-FNA is performed by a skilled endosonographer in a center with a high diagnostic rate, ROSE may offer no benefit to the standard approach [24][25][26][27].…”

Section: Discussionmentioning

confidence: 99%

Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial

et al. 2020

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Background The use of macroscopic on-site evaluation (MOSE) to estimate the adequacy of a specimen for histological diagnosis during endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA) has recently been advocated. This study aimed to evaluate the diagnostic yield of MOSE compared with conventional EUS-FNTA without rapid on-site evaluation (ROSE). Methods This was an international, multicenter, prospective, randomized controlled study. After providing informed consent, consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2 cm were randomized to a MOSE arm or to a conventional arm without ROSE. A designated cytopathologist from each center performed all cytopathological examinations for that center and was blinded to the randomization results. The primary outcome measure was the diagnostic yield, and the secondary outcomes included sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications. Results 244 patients (122 conventional, 122 MOSE) were enrolled during the study period. No significant differences between the two arms were found in procedure time or rate of procedure-related adverse events. The diagnostic yield for the MOSE technique (92.6 %) was similar to that for the conventional technique (89.3 %; P = 0.37), with significantly fewer passes made (median: conventional 3, MOSE 2; P < 0.001). Conclusions EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes. This technique can be used when ROSE is not available.

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“…However, the widespread implementation of this form of evaluation is hampered by a number of factors [1-4]. First, randomized trials and meta-analyses have clearly demonstrated that ROSE does not increase the diagnostic yield or the specimen adequacy of conventional transbronchial needle aspiration (c-TBNA) or endosonography-derived samples from lymphadenopathy [5-11]. As a consequence, according to international guidelines, there is insufficient evidence to recommend the implementation of ROSE for every endosonography procedure [12, 13].…”

Section: Introductionmentioning

confidence: 99%

A Trained Pulmonologist Can Reliably Assess Endosonography-Derived Lymph Node Samples during Rapid On-Site Evaluation

et al. 2019

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Background: The widespread use of rapid on-site evaluation is hampered by constraints related to time and resources, inadequate reimbursement, and evidence from randomized trials that show a lack of increase in diagnostic yield and specimen adequacy associated with its usage. Objective: We aimed to verify whether a pulmonologist can assess endosonography-derived lymph node samples after a comprehensive and reproducible training provided by a specialist pathologist. Methods:Prospective, observational trial structured in three phases. In the first (training) phase, a pathologist critically evaluated the smears from 150 archival endosonography cases with a pulmonologist. In the second (test) phase, the pulmonologist was asked to assess 50 archival endosonography-derived samples. In the last (real-life) phase, the pulmonologist classified the samples from 200 patients during the endosonography. The overall agreement between pulmonologist and pathologist (gold standard), assessed through κ-statistics, was the primary outcome. The agreement for the identification of specific cytological categories was the secondary outcome. Results: The overallagreement between pulmonologist and pathologist was 84% (κ0.765, 95% CI 0.732–0.826) in the test phase and 89.7% (κ 0.844, 95% CI 0.799–0.881) in the real-life phase. The agreement for specific cytological categories was 92.7% (95% CI 0.824–0.980) for inadequate samples, 90.3% (95% CI 84.5–94.5%) for reactive lymphadenopathies, 90.5% (95% CI 0.845–0.946) for malignancy, and 73% (95% CI 0.515–0.897) for granulomatous samples. Conclusions: A trained pulmonologist can reliably assess adequacy and malignancy for endosonography-derived samples, which could be useful in institutions where a cytopathologist/cytotechnician is not available regularly.

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Rapid on-site evaluation during endoscopic ultrasoundguided fine-needle aspiration of lymph nodes does not increase diagnostic yield: A randomized, multicenter trial

Cited by 34 publications

References 36 publications

Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis

Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial

A Trained Pulmonologist Can Reliably Assess Endosonography-Derived Lymph Node Samples during Rapid On-Site Evaluation

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