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Endoscopy 2023; 55(02): 129-137
DOI: 10.1055/a-1915-5263
Original article

Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial

Benedetto Mangiavillano 
 1   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini – Castellanza, Varese, Italy
 2   Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy
,
Stefano Francesco Crinò
 3   Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, G.B. Rossi University Hospital, Verona, Italy
,
Antonio Facciorusso 
 4   Gastroenterology Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy
,
Francesco Di Matteo
 5   Digestive Endoscopy, Università Campus Bio Medico, Rome, Italy
,
Carmelo Barbera
 6   Digestive Endoscopy, Hospital of Teramo, Teramo, Italy
,
Alberto Larghi
 7   Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
,
Gianenrico Rizzatti
 7   Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
,
Silvia Carrara
 8   Humanitas Clinical and Research Center – IRCCS, Rozzano, Milan, Italy
,
Marco Spadaccini
 8   Humanitas Clinical and Research Center – IRCCS, Rozzano, Milan, Italy
,
Francesco Auriemma
 1   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini – Castellanza, Varese, Italy
,
Carlo Fabbri
 9   Endoscopy Unit, Morgagni-Pietrantoni Hospital, Forlì-Cesena, Italy
,
Cecilia Binda 
 9   Endoscopy Unit, Morgagni-Pietrantoni Hospital, Forlì-Cesena, Italy
,
Chiara Coluccio
 9   Endoscopy Unit, Morgagni-Pietrantoni Hospital, Forlì-Cesena, Italy
,
Gianmarco Marocchi 
 9   Endoscopy Unit, Morgagni-Pietrantoni Hospital, Forlì-Cesena, Italy
,
Teresa Staiano
10   Digestive Endoscopy Unit, Candiolo Cancer Institute IRCCS, Candiolo, Turin, Italy
,
Maria Cristina Conti Bellocchi
 3   Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, G.B. Rossi University Hospital, Verona, Italy
,
Laura Bernardoni
 3   Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, G.B. Rossi University Hospital, Verona, Italy
,
Leonardo Henri Eusebi
11   Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, Bologna, Italy
,
Giovanna Grazia Cirota
11   Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, Bologna, Italy
,
Germana De Nucci 
12   Gastroenterology and Endoscopy Unit, ASST Rhodense, Garbagnate Milanese, Milan, Italy
,
Serena Stigliano
 5   Digestive Endoscopy, Università Campus Bio Medico, Rome, Italy
,
Gianpiero Manes 
12   Gastroenterology and Endoscopy Unit, ASST Rhodense, Garbagnate Milanese, Milan, Italy
,
Giacomo Bonanno
13   Digestive Endoscopy, Humanitas – Istituto Clinico Catanese, Catania, Italy
,
Andrew Ofosu
14   Division of Gastroenterology and Hepatology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
,
Laura Lamonaca 
 1   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini – Castellanza, Varese, Italy
,
Danilo Paduano 
 1   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini – Castellanza, Varese, Italy
,
Federica Spatola
 1   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini – Castellanza, Varese, Italy
,
Alessandro Repici
 2   Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy
 8   Humanitas Clinical and Research Center – IRCCS, Rozzano, Milan, Italy
› Author AffiliationsTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT04486274 Type of study: RCT
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The role of macroscopic on-site evaluation in the era of biopsy needles: is it still useful?Endoscopy 2023; 55(02): 138-139
DOI: 10.1055/a-1942-6382

Abstract

Background The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes.

Methods This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety.

Results 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %–93.9 %] vs. 87.8 % [95 %CI 82.1 %–92.2 %]; P = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %–96.3 %] vs. 95.5 % [95 %CI 91.4 %–98 %]; P = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; P = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; P < 0.001).

Conclusions The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.

Table 1 s



Publication History

Received: 02 March 2022

Accepted after revision: 04 July 2022

Article published online:
31 August 2022

© 2022. Thieme. All rights reserved.

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