Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial

Stefano Francesco Crinò; Roberto Di Mitri; Nam Q. Nguyen; Ilaria Tarantino; Germana de Nucci; Pierre H. Deprez; Silvia Carrara; Masayuki Kitano; Vanessa M. Shami; Gloria Fernández-Esparrach; Jan Werner Poley; Francisco Baldaque-Silva; Takao Itoi; Erminia Manfrin; Laura Bernardoni; Armando Gabbrielli; Elisabetta Conte; Elettra Unti; Jeevinesh Naidu; Andrew Ruszkiewicz; Michele Amata; Rosa Liotta; Gianpiero Manes; Franca Di Nuovo; Ivan Borbath; Mina Komuta; Laura Lamonaca; Daoud Rahal; Keiichi Hatamaru; Masahiro Itonaga; Gianenrico Rizzatti; Guido Costamagna; Frediano Inzani; Mariangela Curatolo; Daniel S. Strand; Andrew Y. Wang; Àngels Ginès; Oriol Sendino; Marianna Signoretti; Lydi M.J.W. van Driel; Karoly Dolapcsiev; Yukitoshi Matsunami; Schalk van der Merwe; Hannah van Malenstein; Francesca Locatelli; Loredana Correale; Aldo Scarpa; Alberto Larghi

doi:10.1053/j.gastro.2021.06.005

Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial

Stefano Francesco Crinò^*, Roberto Di Mitri, Nam Q. Nguyen, Ilaria Tarantino, Germana de Nucci, Pierre H. Deprez, Silvia Carrara, Masayuki Kitano, Vanessa M. Shami, Gloria Fernández-Esparrach, Jan Werner Poley, Francisco Baldaque-Silva, Takao Itoi, Erminia Manfrin, Laura Bernardoni, Armando Gabbrielli, Elisabetta Conte, Elettra Unti, Jeevinesh Naidu, Andrew RuszkiewiczMichele Amata, Rosa Liotta, Gianpiero Manes, Franca Di Nuovo, Ivan Borbath, Mina Komuta, Laura Lamonaca, Daoud Rahal, Keiichi Hatamaru, Masahiro Itonaga, Gianenrico Rizzatti, Guido Costamagna, Frediano Inzani, Mariangela Curatolo, Daniel S. Strand, Andrew Y. Wang, Àngels Ginès, Oriol Sendino, Marianna Signoretti, Lydi M.J.W. van Driel, Karoly Dolapcsiev, Yukitoshi Matsunami, Schalk van der Merwe, Hannah van Malenstein, Francesca Locatelli, Loredana Correale, Aldo Scarpa, Alberto Larghi

^*Corresponding author for this work

Gastroenterology & Hepatology

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

70 Citations (Scopus)

Abstract

Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.)

Original language	English
Pages (from-to)	899-909.e5
Journal	Gastroenterology
Volume	161
Issue number	3
DOIs	https://doi.org/10.1053/j.gastro.2021.06.005
Publication status	Published - 1 Sept 2021

Bibliographical note

Funding Information:
Funding This report is an independent research funded by the Associazione Italiana Ricerca sul Cancro (grant AIRC no. 12182 and IG grant no. 24519). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Funding Information:
Conflicts of interest These authors disclose the following: Dr Crinò is a consultant for Boston Scientific. Dr Deprez is a consultant for Boston Scientific. Dr Carrara received a research grant from Boston Scientific . Dr Shami is a consultant for Interpace Diagnostics and Olympus America. Dr Poley is a consultant for and receives travel compensation from Cook Medical, Boston Scientific, and Pentax. Dr Ginès is a consultant for Cook Endoscopy. Dr van Malenstein is a consultant for Boston Scientific. Dr Larghi is a consultant for Pentax and Boston Scientific and received a teaching fee from Medtronic and Boston Scientific. The remaining authors disclose no conflicts.

Funding Information:
Conflicts of interest These authors disclose the following: Dr Crin? is a consultant for Boston Scientific. Dr Deprez is a consultant for Boston Scientific. Dr Carrara received a research grant from Boston Scientific. Dr Shami is a consultant for Interpace Diagnostics and Olympus America. Dr Poley is a consultant for and receives travel compensation from Cook Medical, Boston Scientific, and Pentax. Dr Gin?s is a consultant for Cook Endoscopy. Dr van Malenstein is a consultant for Boston Scientific. Dr Larghi is a consultant for Pentax and Boston Scientific and received a teaching fee from Medtronic and Boston Scientific. The remaining authors disclose no conflicts.Funding This report is an independent research funded by the Associazione Italiana Ricerca sul Cancro (grant AIRC no. 12182 and IG grant no. 24519). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Publisher Copyright:
© 2021 AGA Institute

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10.1053/j.gastro.2021.06.005

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Crinò, S. F., Di Mitri, R., Nguyen, N. Q., Tarantino, I., de Nucci, G., Deprez, P. H., Carrara, S., Kitano, M., Shami, V. M., Fernández-Esparrach, G., Poley, J. W., Baldaque-Silva, F., Itoi, T., Manfrin, E., Bernardoni, L., Gabbrielli, A., Conte, E., Unti, E., Naidu, J., ... Larghi, A. (2021). Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial. Gastroenterology, 161(3), 899-909.e5. https://doi.org/10.1053/j.gastro.2021.06.005

@article{c64975aae192444e91f6e29ac9c6fd17,

title = "Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial",

abstract = "Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.)",

author = "Crin{\`o}, {Stefano Francesco} and {Di Mitri}, Roberto and Nguyen, {Nam Q.} and Ilaria Tarantino and {de Nucci}, Germana and Deprez, {Pierre H.} and Silvia Carrara and Masayuki Kitano and Shami, {Vanessa M.} and Gloria Fern{\'a}ndez-Esparrach and Poley, {Jan Werner} and Francisco Baldaque-Silva and Takao Itoi and Erminia Manfrin and Laura Bernardoni and Armando Gabbrielli and Elisabetta Conte and Elettra Unti and Jeevinesh Naidu and Andrew Ruszkiewicz and Michele Amata and Rosa Liotta and Gianpiero Manes and {Di Nuovo}, Franca and Ivan Borbath and Mina Komuta and Laura Lamonaca and Daoud Rahal and Keiichi Hatamaru and Masahiro Itonaga and Gianenrico Rizzatti and Guido Costamagna and Frediano Inzani and Mariangela Curatolo and Strand, {Daniel S.} and Wang, {Andrew Y.} and {\`A}ngels Gin{\`e}s and Oriol Sendino and Marianna Signoretti and {van Driel}, {Lydi M.J.W.} and Karoly Dolapcsiev and Yukitoshi Matsunami and {van der Merwe}, Schalk and {van Malenstein}, Hannah and Francesca Locatelli and Loredana Correale and Aldo Scarpa and Alberto Larghi",

note = "Funding Information: Funding This report is an independent research funded by the Associazione Italiana Ricerca sul Cancro (grant AIRC no. 12182 and IG grant no. 24519). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Funding Information: Conflicts of interest These authors disclose the following: Dr Crin{\`o} is a consultant for Boston Scientific. Dr Deprez is a consultant for Boston Scientific. Dr Carrara received a research grant from Boston Scientific . Dr Shami is a consultant for Interpace Diagnostics and Olympus America. Dr Poley is a consultant for and receives travel compensation from Cook Medical, Boston Scientific, and Pentax. Dr Gin{\`e}s is a consultant for Cook Endoscopy. Dr van Malenstein is a consultant for Boston Scientific. Dr Larghi is a consultant for Pentax and Boston Scientific and received a teaching fee from Medtronic and Boston Scientific. The remaining authors disclose no conflicts. Funding Information: Conflicts of interest These authors disclose the following: Dr Crin? is a consultant for Boston Scientific. Dr Deprez is a consultant for Boston Scientific. Dr Carrara received a research grant from Boston Scientific. Dr Shami is a consultant for Interpace Diagnostics and Olympus America. Dr Poley is a consultant for and receives travel compensation from Cook Medical, Boston Scientific, and Pentax. Dr Gin?s is a consultant for Cook Endoscopy. Dr van Malenstein is a consultant for Boston Scientific. Dr Larghi is a consultant for Pentax and Boston Scientific and received a teaching fee from Medtronic and Boston Scientific. The remaining authors disclose no conflicts.Funding This report is an independent research funded by the Associazione Italiana Ricerca sul Cancro (grant AIRC no. 12182 and IG grant no. 24519). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Publisher Copyright: {\textcopyright} 2021 AGA Institute",

year = "2021",

month = sep,

day = "1",

doi = "10.1053/j.gastro.2021.06.005",

language = "English",

volume = "161",

pages = "899--909.e5",

journal = "Gastroenterology",

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Crinò, SF, Di Mitri, R, Nguyen, NQ, Tarantino, I, de Nucci, G, Deprez, PH, Carrara, S, Kitano, M, Shami, VM, Fernández-Esparrach, G, Poley, JW, Baldaque-Silva, F, Itoi, T, Manfrin, E, Bernardoni, L, Gabbrielli, A, Conte, E, Unti, E, Naidu, J, Ruszkiewicz, A, Amata, M, Liotta, R, Manes, G, Di Nuovo, F, Borbath, I, Komuta, M, Lamonaca, L, Rahal, D, Hatamaru, K, Itonaga, M, Rizzatti, G, Costamagna, G, Inzani, F, Curatolo, M, Strand, DS, Wang, AY, Ginès, À, Sendino, O, Signoretti, M, van Driel, LMJW, Dolapcsiev, K, Matsunami, Y, van der Merwe, S, van Malenstein, H, Locatelli, F, Correale, L, Scarpa, A & Larghi, A 2021, 'Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial', Gastroenterology, vol. 161, no. 3, pp. 899-909.e5. https://doi.org/10.1053/j.gastro.2021.06.005

Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial. / Crinò, Stefano Francesco; Di Mitri, Roberto; Nguyen, Nam Q. et al.
In: Gastroenterology, Vol. 161, No. 3, 01.09.2021, p. 899-909.e5.

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

TY - JOUR

T1 - Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions

T2 - A Randomized Controlled Non-Inferiority Trial

AU - Crinò, Stefano Francesco

AU - Di Mitri, Roberto

AU - Nguyen, Nam Q.

AU - Tarantino, Ilaria

AU - de Nucci, Germana

AU - Deprez, Pierre H.

AU - Carrara, Silvia

AU - Kitano, Masayuki

AU - Shami, Vanessa M.

AU - Fernández-Esparrach, Gloria

AU - Poley, Jan Werner

AU - Baldaque-Silva, Francisco

AU - Itoi, Takao

AU - Manfrin, Erminia

AU - Bernardoni, Laura

AU - Gabbrielli, Armando

AU - Conte, Elisabetta

AU - Unti, Elettra

AU - Naidu, Jeevinesh

AU - Ruszkiewicz, Andrew

AU - Amata, Michele

AU - Liotta, Rosa

AU - Manes, Gianpiero

AU - Di Nuovo, Franca

AU - Borbath, Ivan

AU - Komuta, Mina

AU - Lamonaca, Laura

AU - Rahal, Daoud

AU - Hatamaru, Keiichi

AU - Itonaga, Masahiro

AU - Rizzatti, Gianenrico

AU - Costamagna, Guido

AU - Inzani, Frediano

AU - Curatolo, Mariangela

AU - Strand, Daniel S.

AU - Wang, Andrew Y.

AU - Ginès, Àngels

AU - Sendino, Oriol

AU - Signoretti, Marianna

AU - van Driel, Lydi M.J.W.

AU - Dolapcsiev, Karoly

AU - Matsunami, Yukitoshi

AU - van der Merwe, Schalk

AU - van Malenstein, Hannah

AU - Locatelli, Francesca

AU - Correale, Loredana

AU - Scarpa, Aldo

AU - Larghi, Alberto

N1 - Funding Information: Funding This report is an independent research funded by the Associazione Italiana Ricerca sul Cancro (grant AIRC no. 12182 and IG grant no. 24519). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Funding Information: Conflicts of interest These authors disclose the following: Dr Crinò is a consultant for Boston Scientific. Dr Deprez is a consultant for Boston Scientific. Dr Carrara received a research grant from Boston Scientific . Dr Shami is a consultant for Interpace Diagnostics and Olympus America. Dr Poley is a consultant for and receives travel compensation from Cook Medical, Boston Scientific, and Pentax. Dr Ginès is a consultant for Cook Endoscopy. Dr van Malenstein is a consultant for Boston Scientific. Dr Larghi is a consultant for Pentax and Boston Scientific and received a teaching fee from Medtronic and Boston Scientific. The remaining authors disclose no conflicts. Funding Information: Conflicts of interest These authors disclose the following: Dr Crin? is a consultant for Boston Scientific. Dr Deprez is a consultant for Boston Scientific. Dr Carrara received a research grant from Boston Scientific. Dr Shami is a consultant for Interpace Diagnostics and Olympus America. Dr Poley is a consultant for and receives travel compensation from Cook Medical, Boston Scientific, and Pentax. Dr Gin?s is a consultant for Cook Endoscopy. Dr van Malenstein is a consultant for Boston Scientific. Dr Larghi is a consultant for Pentax and Boston Scientific and received a teaching fee from Medtronic and Boston Scientific. The remaining authors disclose no conflicts.Funding This report is an independent research funded by the Associazione Italiana Ricerca sul Cancro (grant AIRC no. 12182 and IG grant no. 24519). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Publisher Copyright: © 2021 AGA Institute

PY - 2021/9/1

Y1 - 2021/9/1

N2 - Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.)

AB - Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.)

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U2 - 10.1053/j.gastro.2021.06.005

DO - 10.1053/j.gastro.2021.06.005

M3 - Article

C2 - 34116031

AN - SCOPUS:85108122282

SN - 0016-5085

VL - 161

SP - 899-909.e5

JO - Gastroenterology

JF - Gastroenterology

IS - 3

ER -

Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial

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