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

被引：122

作者：

Crino, Stefano Francesco ^{[1
]}

Di Mitri, Roberto ^{[2
]}

Nguyen, Nam Q. ^{[3
]}

Tarantino, Ilaria ^{[4
]}

de Nucci, Germana ^{[5
]}

Deprez, Pierre H. ^{[6
]}

Carrara, Silvia ^{[7
]}

Kitano, Masayuki ^{[8
]}

Shami, Vanessa M. ^{[9
]}

Fernandez-Esparrach, Gloria ^{[10
]}

Poley, Jan-Werner ^{[11
]}

Baldaque-Silva, Francisco ^{[12
,13
]}

Itoi, Takao ^{[14
]}

Manfrin, Erminia ^{[15
]}

Bernardoni, Laura ^{[1
]}

Gabbrielli, Armando ^{[1
]}

Conte, Elisabetta ^{[2
]}

Unti, Elettra ^{[16
]}

Naidu, Jeevinesh ^{[3
]}

Ruszkiewicz, Andrew ^{[17
]}

Amata, Michele ^{[4
]}

Liotta, Rosa ^{[18
]}

Manes, Gianpiero ^{[5
]}

Di Nuovo, Franca ^{[19
]}

Borbath, Ivan ^{[6
]}

Komuta, Mina ^{[20
,21
]}

Lamonaca, Laura ^{[7
]}

Rahal, Daoud ^{[22
]}

Hatamaru, Keiichi ^{[8
]}

Itonaga, Masahiro ^{[8
]}

Rizzatti, Gianenrico ^{[23
]}

Costamagna, Guido ^{[23
,24
]}

Inzani, Frediano ^{[25
]}

Curatolo, Mariangela ^{[25
]}

Strand, Daniel S. ^{[9
]}

Wang, Andrew Y. ^{[9
]}

Gines, Angels ^{[10
]}

Sendino, Oriol ^{[10
]}

Signoretti, Marianna ^{[11
,26
]}

van Driel, Lydi M. J. W. ^{[11
]}

Dolapcsiev, Karoly ^{[27
]}

Matsunami, Yukitoshi ^{[14
]}

van der Merwe, Schalk ^{[28
]}

van Malenstein, Hannah ^{[28
]}

Locatelli, Francesca ^{[29
]}

Correale, Loredana ^{[1
]}

Scarpa, Aldo ^{[15
,30
]}

Larghi, Alberto ^{[23
,24
]}

机构：

[1] GB Rossi Univ Hosp, Pancreas Inst, Digest Endoscopy Unit, Verona, Italy

[2] ARNAS Civ Cristina Benfratelli Hosp, Gastroenterol & Endoscopy Unit, Palermo, Italy

[3] Royal Adelaide Hosp, Dept Gastroenterol, Adelaide, SA, Australia

[4] Mediterranean Inst Transplantat & Adv Specialized, Dept Diagnost & Therapeut Serv, Endoscopy Serv, Palermo, Italy

[5] Rho & Garbagnate Milanese Hosp, Dept Gastroenterol, ASST Rhodense, Milan, Italy

[6] Catholic Univ Louvain, Dept Gastroenterol & Hepatol, Clin Univ St Luc, Brussels, Belgium

[7] Humanitas Clin & Res Ctr IRCCS, Dept Gastroenterol, Endoscop Unit, Milan, Italy

[8] Wakayama Med Univ, Dept Internal Med 2, Wakayama, Japan

[9] Univ Virginia Hlth Syst, Div Gastroenterol & Hepatol, Charlottesville, VA USA

[10] Univ Barcelona, Hosp Clin Barcelona, Dept Gastroenterol, IDIBAPS,CIBEREHD,Endoscopy Unit, Barcelona, Spain

[11] Univ Med Ctr Rotterdam, Dept Gastroenterol & Hepatol, Erasmus MC, Rotterdam, Netherlands

[12] Karolinska Univ Hosp, Dept Upper GI Dis, Unit Gastrointestinal Endoscopy, Stockholm, Sweden

[13] Karolinska Inst, Stockholm, Sweden

[14] Tokyo Med Univ, Dept Gastroenterol & Hepatol, Shinjuku Ku, Tokyo, Japan

[15] GB Rossi Univ Hosp, Dept Diagnost & Publ Hlth, Sect Pathol, Verona, Italy

[16] ARNAS Civ Cristina Benfratelli Hosp, Pathol Unit, Palermo, Italy

[17] Royal Adelaide Hosp, SA Pathol Adelaide, Adelaide, SA, Australia

[18] Mediterranean Inst Transplantat & Adv Specialized, Dept Diagnost & Therapeut Serv, Pathol Serv, Palermo, Italy

[19] ASST Rhodense, Pathol Unit, Garbagnate Milanese, MI, Italy

[20] Keio Univ, Sch Med, Dept Pathol, Tokyo, Japan

[21] Catholic Univ Louvain, Dept Pathol, Clin Univ St Luc, Brussels, Belgium

[22] Humanitas Clin & Res Ctr IRCCS, Dept Pathol, Milan, Italy

[23] Fdn Policlin Univ A Gemelli IRCCS, Digest Endoscopy Unit, Rome, Italy

[24] Catholic Univ, CERTT, Ctr Endoscop Res Therapeut & Training, Rome, Italy

[25] Fdn Policlin Univ A Gemelli IRCCS, Pathol Unit, Rome, Italy

[26] Sapienza Univ, Digest & Liver Dis Unit, St Andrea Hosp, Rome, Italy

[27] Karolinska Univ Hosp, Karolinska Univ Lab, Dept Pathol, Stockholm, Sweden

[28] Katholieke Univ Leuven, Dept Gastroenterol & Hepatol, Univ Hosp Leuven, Leuven, Belgium

[29] GB Rossi Univ Hosp, Dept Diagnost & Publ Hlth, Unit Epidemiol & Med Stat, Verona, Italy

[30] Univ Verona, GB Rossi Univ Hosp, ARC Net Res Ctr, Verona, Italy

来源：

GASTROENTEROLOGY | 2021年 / 161卷 / 03期

关键词：

Pancreatic Cancer; Preoperative Sampling; Endoscopic Ultrasound Tissue Acquisition; Diagnostic Accuracy; FORK-TIP NEEDLE; TISSUE ACQUISITION; CYTOPATHOLOGY EVALUATION; ASPIRATION; MASSES; FNA; PERFORMANCE; ACCURACY; CYTOLOGY; IMPACT;

D O I：

10.1053/j.gastro.2021.06.005

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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 signifi- cantly 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.

引用

页码：899 / +

页数：16

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