Charing C N Chong1, Sundeep Lakhtakia2, Nam Nguyen3, Kazuo Hara4, Wah Kheong Chan5, Rajesh Puri6, Majid A Almadi7, Tiing Leong Ang8, Andrew Kwek8, Ichiro Yasuda9, Shinpei Doi9, Mitsuhiro Kida10, Hsiu-Po Wang11, Tsu-Yao Cheng11, Qingwei Jiang12, Aiming Yang12, Anthony W H Chan13, Shannon Chan1, Raymond Tang14, Takuji Iwashita15, Anthony Y B Teoh1. 1. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. 2. Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India. 3. Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia. 4. Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan. 5. Department of Medicine, Faculty of Medicine, University of Malaya Medical Center, University of Malaya, Kuala Lumpur, Malaysia. 6. Department of Gastroenterology and Hepatology, Medanta, The Medicity, Gurgaon, India. 7. Division of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia. 8. Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore. 9. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan. 10. Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan. 11. Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan. 12. Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China. 13. Department of Anatomical and Cellular Pathology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. 14. Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. 15. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
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. Thieme. All rights reserved.
RCT Entities:
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. Thieme. All rights reserved.
Authors: Benedetto Mangiavillano; Leonardo Frazzoni; Thomas Togliani; Carlo Fabbri; Ilaria Tarantino; Luca De Luca; Teresa Staiano; Cecilia Binda; Marianna Signoretti; Leonardo H Eusebi; Francesco Auriemma; Laura Lamonaca; Danilo Paduano; Milena Di Leo; Silvia Carrara; Lorenzo Fuccio; Alessandro Repici Journal: Endosc Int Open Date: 2021-05-27