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Endoscopy 2019; 51(05): 444-451
DOI: 10.1055/a-0790-8342
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Forward-viewing echoendoscope versus standard echoendoscope for endoscopic ultrasound-guided tissue acquisition of solid lesions: a randomized, multicenter study

Alberto Larghi
1   Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
,
Mostafa Ibrahim
2   Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme University Hospital – Université Libre de Bruxelles, Brussels, Belgium
,
Lorenzo Fuccio
3   Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
,
Selma Lekkerkerker
4   Department of Gastroenterology and Hepatology Academic Medical Center University of Amsterdam, Amsterdam, The Netherlands
,
Pierre Eisendrath
2   Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme University Hospital – Université Libre de Bruxelles, Brussels, Belgium
,
Leonardo Frazzoni
3   Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
,
Paul Fockens
4   Department of Gastroenterology and Hepatology Academic Medical Center University of Amsterdam, Amsterdam, The Netherlands
,
Marina La Marca
3   Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
,
Jeanin E. van Hooft
4   Department of Gastroenterology and Hepatology Academic Medical Center University of Amsterdam, Amsterdam, The Netherlands
,
Jacques Deviere
2   Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme University Hospital – Université Libre de Bruxelles, Brussels, Belgium
,
Guido Costamagna
1   Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
5   Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore, IRCCS, Rome, Italy
6   IHU-USIAS, University of Strasbourg, Strasbourg, France
› Author AffiliationsTRIAL REGISTRATION: Multicenter prospective randomized comparative study NCT01673945 at clinicaltrials.gov
Further Information

Publication History

submitted09 March 2018

accepted after revision20 September 2018

Publication Date:
29 November 2018 (online)

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Abstract

Background A forward-viewing linear (FVL) echoendoscope has been developed with the aim of overcoming some of the limitations of standard curved linear-array (CLA) echoendoscopes. There are no existing studies comparing the performance of the two echoendoscopes for endoscopic ultrasound-guided tissue acquisition (EUS-TA) of solid lesions other than subepithelial lesions.

Methods This was a prospective, multicenter, randomized trial with a noninferiority design comparing FVL vs. CLA echoendoscopes in patients with solid lesions of the gastrointestinal tract or adjacent organs. Primary outcomes were successful identification of the lesion and success of EUS-TA. Secondary outcomes were safety, sensitivity, specificity, and diagnostic accuracy of the two different scopes for EUS-TA.

Results 126 patients with solid lesions were randomly assigned to the CLA group (63 patients) or the FVL group (63 patients). The two groups were homogeneous with no differences in terms of needle type used, mean number of passes, and site of EUS-TA. No differences were observed between the FVL vs. CLA scopes in identification of the lesion (96.8 % vs. 98.4 %; P > 0.99) and technical success of EUS-TA (92.1 % vs. 96.8 %; P = 0.44). No adverse events occurred. Overall, diagnostic accuracy (77.8 % vs. 84.1 %), sensitivity (76.6 % vs. 84.1 %), and specificity (81.3 % vs. 84.2 %) did not differ between the two groups.

Conclusions Our results strongly suggest that the FVL echoendoscope is noninferior to the CLA scope for the detection and performance of EUS-TA in patients with solid lesions of the gastrointestinal tract and adjacent organs. In addition, the FVL scope has the same diagnostic yield, accuracy, and safety as the CLA scope.

 

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