Endoscopy 2020; 52(10): 856-863
DOI: 10.1055/a-1172-6027
Original article

Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial

Charing C. N. Chong
1  Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong
,
Sundeep Lakhtakia
2  Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
,
Nam Nguyen
3  Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia
,
Kazuo Hara
4  Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan
,
Wah Kheong Chan
5  Department of Medicine, Faculty of Medicine, University of Malaya Medical Center, University of Malaya, Kuala Lumpur, Malaysia
,
Rajesh Puri
6  Department of Gastroenterology and Hepatology, Medanta, The Medicity, Gurgaon, India
,
Majid A. Almadi
7  Division of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia
,
Tiing Leong Ang
8  Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore
,
Andrew Kwek
8  Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore
,
Ichiro Yasuda
9  Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan
,
Shinpei Doi
9  Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan
,
Mitsuhiro Kida
10  Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan
,
Hsiu-Po Wang
11  Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
,
Tsu-Yao Cheng
11  Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
,
Qingwei Jiang
12  Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
,
Aiming Yang
12  Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
,
Anthony W. H. Chan
13  Department of Anatomical and Cellular Pathology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong
,
Shannon Chan
1  Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong
,
Raymond Tang
14  Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong
,
Takuji Iwashita
15  First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan
,
Anthony Y. B. Teoh
1  Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong
› Institutsangaben
Trial registry: ClinicalTrials.gov Registration number (trial ID): NCT03130140 Type of study: Multi-center prospective randomized controlled trial

Abstract

Background The use of macroscopic on-site evaluation (MOSE) to estimate the adequacy of a specimen for histological diagnosis during endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA) has recently been advocated. This study aimed to evaluate the diagnostic yield of MOSE compared with conventional EUS-FNTA without rapid on-site evaluation (ROSE).

Methods This was an international, multicenter, prospective, randomized controlled study. After providing informed consent, consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2 cm were randomized to a MOSE arm or to a conventional arm without ROSE. A designated cytopathologist from each center performed all cytopathological examinations for that center and was blinded to the randomization results. The primary outcome measure was the diagnostic yield, and the secondary outcomes included sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications.

Results 244 patients (122 conventional, 122 MOSE) were enrolled during the study period. No significant differences between the two arms were found in procedure time or rate of procedure-related adverse events. The diagnostic yield for the MOSE technique (92.6 %) was similar to that for the conventional technique (89.3 %; P  = 0.37), with significantly fewer passes made (median: conventional 3, MOSE 2; P  < 0.001).

Conclusions EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes. This technique can be used when ROSE is not available.

Supplementary material



Publikationsverlauf

Eingereicht: 08. Januar 2020

Angenommen: 14. April 2020

Publikationsdatum:
04. Juni 2020 (online)

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