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

W. F.W. Kappelle; M. E. Van Leerdam; M. P. Schwartz; M. Bülbül; W. A. Buikhuisen; M. A. Brink; D. M.D.S. Sie-Go; H. J.M. Pullens; S. Nikolakopoulos; P. J. Van Diest; M. Leenders; L. M.G. Moons; A. Bogte; P. D. Siersema; F. P. Vleggaar

doi:10.1038/s41395-018-0025-8

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

W. F.W. Kappelle^*, M. E. Van Leerdam, M. P. Schwartz, M. Bülbül, W. A. Buikhuisen, M. A. Brink, D. M.D.S. Sie-Go, H. J.M. Pullens, S. Nikolakopoulos, P. J. Van Diest, M. Leenders, L. M.G. Moons, A. Bogte, P. D. Siersema, F. P. Vleggaar

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Objectives: Studies on the impact of rapid on-site evaluation (ROSE) during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of lymph nodes are retrospective and have shown conflicting results. We aimed to compare the diagnostic yield of EUS-FNA of lymph nodes with ROSE (ROSE+) and without ROSE (ROSE-). Methods: This was a multicenter, randomized controlled trial. Consecutive patients who were scheduled to undergo EUS-FNA of mediastinal or abdominal lymph nodes were randomized to ROSE+ or ROSE-. In the ROSE+ group, the number of passes was dictated by the on-site cytotechnician. In the ROSE- group, five passes were performed without interference from the cytotechnician. All samples were reviewed by a single-expert cytopathologist, blinded to group allocation. Primary endpoint was diagnostic yield with and without ROSE. Results: After inclusion of 90 patients, interim analysis showed futility of study continuation since diagnostic yield of ROSE+ and ROSE- were comparable. A total of 91 patients were randomized to ROSE+ (N = 45) or ROSE- (N = 46). Diagnostic yield of ROSE+ and ROSE- and diagnostic accuracy were comparable: 93.3% vs. 95.7% (P = 0.68) and 97.6% vs. 93.2% (P = 0.62), respectively. Two major complications (one per group) occurred (p = 0.99). ROSE- patients more often reported self-limiting post-procedural pain (p < 0.001). Median procedure time for ROSE+ (20 min) and ROSE- (23 min) was comparable (P = 0.06). Median time to review slides in the ROSE- group (12:47 min) was longer than with ROSE+ (7:52 min) (P < 0.001). Mean costs of ROSE- and ROSE+ were comparable: €938.29 (±172.70) vs. €945.98 (±223.38) (P = 0.91), respectively. Conclusions: Diagnostic yield and accuracy of EUS-FNA of mediastinal and abdominal lymph nodes with and without ROSE are comparable. Time needed to review slides was shorter and post-procedural pain was less often reported in the ROSE+ group. Based on the primary outcome, the implementation of ROSE during EUS-FNA of mediastinal and abdominal lymph nodes cannot be advised.

Original language	English
Pages (from-to)	677-685
Number of pages	9
Journal	American Journal of Gastroenterology
Volume	113
Issue number	5
DOIs	https://doi.org/10.1038/s41395-018-0025-8
Publication status	Published - 1 May 2018

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Kappelle, W. F. W., Van Leerdam, M. E., Schwartz, M. P., Bülbül, M., Buikhuisen, W. A., Brink, M. A., Sie-Go, D. M. D. S., Pullens, H. J. M., Nikolakopoulos, S., Van Diest, P. J., Leenders, M., Moons, L. M. G., Bogte, A., Siersema, P. D., & Vleggaar, F. P. (2018). Rapid on-site evaluation during endoscopic ultrasound-guided fine-needle aspiration of lymph nodes does not increase diagnostic yield: A randomized, multicenter trial. American Journal of Gastroenterology, 113(5), 677-685. https://doi.org/10.1038/s41395-018-0025-8

@article{323e18dd9fe44d05a87c61c6e3ff5ead,

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

abstract = "Objectives: Studies on the impact of rapid on-site evaluation (ROSE) during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of lymph nodes are retrospective and have shown conflicting results. We aimed to compare the diagnostic yield of EUS-FNA of lymph nodes with ROSE (ROSE+) and without ROSE (ROSE-). Methods: This was a multicenter, randomized controlled trial. Consecutive patients who were scheduled to undergo EUS-FNA of mediastinal or abdominal lymph nodes were randomized to ROSE+ or ROSE-. In the ROSE+ group, the number of passes was dictated by the on-site cytotechnician. In the ROSE- group, five passes were performed without interference from the cytotechnician. All samples were reviewed by a single-expert cytopathologist, blinded to group allocation. Primary endpoint was diagnostic yield with and without ROSE. Results: After inclusion of 90 patients, interim analysis showed futility of study continuation since diagnostic yield of ROSE+ and ROSE- were comparable. A total of 91 patients were randomized to ROSE+ (N = 45) or ROSE- (N = 46). Diagnostic yield of ROSE+ and ROSE- and diagnostic accuracy were comparable: 93.3% vs. 95.7% (P = 0.68) and 97.6% vs. 93.2% (P = 0.62), respectively. Two major complications (one per group) occurred (p = 0.99). ROSE- patients more often reported self-limiting post-procedural pain (p < 0.001). Median procedure time for ROSE+ (20 min) and ROSE- (23 min) was comparable (P = 0.06). Median time to review slides in the ROSE- group (12:47 min) was longer than with ROSE+ (7:52 min) (P < 0.001). Mean costs of ROSE- and ROSE+ were comparable: €938.29 (±172.70) vs. €945.98 (±223.38) (P = 0.91), respectively. Conclusions: Diagnostic yield and accuracy of EUS-FNA of mediastinal and abdominal lymph nodes with and without ROSE are comparable. Time needed to review slides was shorter and post-procedural pain was less often reported in the ROSE+ group. Based on the primary outcome, the implementation of ROSE during EUS-FNA of mediastinal and abdominal lymph nodes cannot be advised.",

author = "Kappelle, {W. F.W.} and {Van Leerdam}, {M. E.} and Schwartz, {M. P.} and M. B{\"u}lb{\"u}l and Buikhuisen, {W. A.} and Brink, {M. A.} and Sie-Go, {D. M.D.S.} and Pullens, {H. J.M.} and S. Nikolakopoulos and {Van Diest}, {P. J.} and M. Leenders and Moons, {L. M.G.} and A. Bogte and Siersema, {P. D.} and Vleggaar, {F. P.}",

note = "Publisher Copyright: {\textcopyright} 2018 American College of Gastroenterology.",

year = "2018",

month = may,

day = "1",

doi = "10.1038/s41395-018-0025-8",

language = "English",

volume = "113",

pages = "677--685",

journal = "American Journal of Gastroenterology",

issn = "0002-9270",

publisher = "Nature Publishing Group",

number = "5",

}

Kappelle, WFW, Van Leerdam, ME, Schwartz, MP, Bülbül, M, Buikhuisen, WA, Brink, MA, Sie-Go, DMDS, Pullens, HJM, Nikolakopoulos, S , Van Diest, PJ, Leenders, M, Moons, LMG, Bogte, A, Siersema, PD & Vleggaar, FP 2018, 'Rapid on-site evaluation during endoscopic ultrasound-guided fine-needle aspiration of lymph nodes does not increase diagnostic yield: A randomized, multicenter trial', American Journal of Gastroenterology, vol. 113, no. 5, pp. 677-685. https://doi.org/10.1038/s41395-018-0025-8

Rapid on-site evaluation during endoscopic ultrasound-guided fine-needle aspiration of lymph nodes does not increase diagnostic yield: A randomized, multicenter trial. / Kappelle, W. F.W.; Van Leerdam, M. E.; Schwartz, M. P. et al.
In: American Journal of Gastroenterology, Vol. 113, No. 5, 01.05.2018, p. 677-685.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Rapid on-site evaluation during endoscopic ultrasound-guided fine-needle aspiration of lymph nodes does not increase diagnostic yield

T2 - A randomized, multicenter trial

AU - Kappelle, W. F.W.

AU - Van Leerdam, M. E.

AU - Schwartz, M. P.

AU - Bülbül, M.

AU - Buikhuisen, W. A.

AU - Brink, M. A.

AU - Sie-Go, D. M.D.S.

AU - Pullens, H. J.M.

AU - Nikolakopoulos, S.

AU - Van Diest, P. J.

AU - Leenders, M.

AU - Moons, L. M.G.

AU - Bogte, A.

AU - Siersema, P. D.

AU - Vleggaar, F. P.

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Objectives: Studies on the impact of rapid on-site evaluation (ROSE) during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of lymph nodes are retrospective and have shown conflicting results. We aimed to compare the diagnostic yield of EUS-FNA of lymph nodes with ROSE (ROSE+) and without ROSE (ROSE-). Methods: This was a multicenter, randomized controlled trial. Consecutive patients who were scheduled to undergo EUS-FNA of mediastinal or abdominal lymph nodes were randomized to ROSE+ or ROSE-. In the ROSE+ group, the number of passes was dictated by the on-site cytotechnician. In the ROSE- group, five passes were performed without interference from the cytotechnician. All samples were reviewed by a single-expert cytopathologist, blinded to group allocation. Primary endpoint was diagnostic yield with and without ROSE. Results: After inclusion of 90 patients, interim analysis showed futility of study continuation since diagnostic yield of ROSE+ and ROSE- were comparable. A total of 91 patients were randomized to ROSE+ (N = 45) or ROSE- (N = 46). Diagnostic yield of ROSE+ and ROSE- and diagnostic accuracy were comparable: 93.3% vs. 95.7% (P = 0.68) and 97.6% vs. 93.2% (P = 0.62), respectively. Two major complications (one per group) occurred (p = 0.99). ROSE- patients more often reported self-limiting post-procedural pain (p < 0.001). Median procedure time for ROSE+ (20 min) and ROSE- (23 min) was comparable (P = 0.06). Median time to review slides in the ROSE- group (12:47 min) was longer than with ROSE+ (7:52 min) (P < 0.001). Mean costs of ROSE- and ROSE+ were comparable: €938.29 (±172.70) vs. €945.98 (±223.38) (P = 0.91), respectively. Conclusions: Diagnostic yield and accuracy of EUS-FNA of mediastinal and abdominal lymph nodes with and without ROSE are comparable. Time needed to review slides was shorter and post-procedural pain was less often reported in the ROSE+ group. Based on the primary outcome, the implementation of ROSE during EUS-FNA of mediastinal and abdominal lymph nodes cannot be advised.

AB - Objectives: Studies on the impact of rapid on-site evaluation (ROSE) during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of lymph nodes are retrospective and have shown conflicting results. We aimed to compare the diagnostic yield of EUS-FNA of lymph nodes with ROSE (ROSE+) and without ROSE (ROSE-). Methods: This was a multicenter, randomized controlled trial. Consecutive patients who were scheduled to undergo EUS-FNA of mediastinal or abdominal lymph nodes were randomized to ROSE+ or ROSE-. In the ROSE+ group, the number of passes was dictated by the on-site cytotechnician. In the ROSE- group, five passes were performed without interference from the cytotechnician. All samples were reviewed by a single-expert cytopathologist, blinded to group allocation. Primary endpoint was diagnostic yield with and without ROSE. Results: After inclusion of 90 patients, interim analysis showed futility of study continuation since diagnostic yield of ROSE+ and ROSE- were comparable. A total of 91 patients were randomized to ROSE+ (N = 45) or ROSE- (N = 46). Diagnostic yield of ROSE+ and ROSE- and diagnostic accuracy were comparable: 93.3% vs. 95.7% (P = 0.68) and 97.6% vs. 93.2% (P = 0.62), respectively. Two major complications (one per group) occurred (p = 0.99). ROSE- patients more often reported self-limiting post-procedural pain (p < 0.001). Median procedure time for ROSE+ (20 min) and ROSE- (23 min) was comparable (P = 0.06). Median time to review slides in the ROSE- group (12:47 min) was longer than with ROSE+ (7:52 min) (P < 0.001). Mean costs of ROSE- and ROSE+ were comparable: €938.29 (±172.70) vs. €945.98 (±223.38) (P = 0.91), respectively. Conclusions: Diagnostic yield and accuracy of EUS-FNA of mediastinal and abdominal lymph nodes with and without ROSE are comparable. Time needed to review slides was shorter and post-procedural pain was less often reported in the ROSE+ group. Based on the primary outcome, the implementation of ROSE during EUS-FNA of mediastinal and abdominal lymph nodes cannot be advised.

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U2 - 10.1038/s41395-018-0025-8

DO - 10.1038/s41395-018-0025-8

M3 - Article

C2 - 29681624

SN - 0002-9270

VL - 113

SP - 677

EP - 685

JO - American Journal of Gastroenterology

JF - American Journal of Gastroenterology

IS - 5

ER -

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

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