PMID- 35693609
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2072-1439 (Print)
IS  - 2077-6624 (Electronic)
IS  - 2072-1439 (Linking)
VI  - 14
IP  - 5
DP  - 2022 May
TI  - Study design for a multicenter, randomized controlled trial evaluating the 
      diagnostic value of ultrathin bronchoscope compared to thin bronchoscope without 
      fluoroscopy for peripheral pulmonary lesions.
PG  - 1663-1673
LID - 10.21037/jtd-22-20 [doi]
AB  - BACKGROUND: Ultrathin bronchoscope (UTB) with a 3.0-mm outer diameter and a 
      1.7-mm working channel currently appeared as a potential tool for better biopsy 
      and diagnosis of peripheral pulmonary lesions (PPLs) by accessing more distal 
      bronchus. However, published research is primarily limited to diagnosis value of 
      UTB for PPLs with fluoroscopy, the value of UTB compared with thin bronchoscope 
      (TB) without fluoroscopy guidance has not been determined yet. METHODS: We design 
      a prospective, randomized, controlled, non-inferior, multicenter study aiming to 
      evaluate the diagnostic value and safety of UTB for PPLs with the guidance of 
      virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound 
      (EBUS) without fluoroscopy by comparing to TB. The study aims to enroll 578 
      patients presenting for evaluation of PPLs at five clinical sites in China. 
      Subjects will be randomized to UTB-VBN-EBUS group, TB-VBN-EBUS-guide sheath (GS) 
      group, and TB-VBN-EBUS-non-GS group. Primary endpoint is the diagnostic yield of 
      PPLs. The total examination time, duration of finding lesions, the proportion of 
      lesions visible by radial EBUS, factors affecting the diagnostic yield, 
      difference in the bronchus level reached with the bronchoscope, difference in 
      diagnostic yield, and complication rate will be determined as secondary 
      endpoints. The primary endpoint will be followed-up at least 6-month 
      post-procedure and 1-month post-procedure for safety endpoint. DISCUSSION: Study 
      enrollment began in March 2021. Our preliminary experience reveals that UTB is a 
      powerful tool in the diagnosis of PPLs even without fluoroscopy. The results of 
      the current study will compensate the limitations of the previous research, 
      further provide evidence of UTB in diagnosing PPLs without fluoroscopy. TRIAL 
      REGISTRATION: ClinicalTrials.gov NCT04571476. Registered on 30 September 2020.
CI  - 2022 Journal of Thoracic Disease. All rights reserved.
FAU - Feng, Xintong
AU  - Feng X
AD  - Department of Respiratory Endoscopy, Department of Respiratory and Critical Care 
      Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 
      China.
AD  - Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
FAU - Zhang, Qin
AU  - Zhang Q
AD  - Department of Respiratory Endoscopy, Department of Respiratory and Critical Care 
      Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 
      China.
AD  - Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
FAU - Luo, Fengming
AU  - Luo F
AD  - Department of Respiratory and Critical Care Medicine, West China Hospital, 
      Sichuan University, Chengdu, China.
FAU - Zhang, Xiaoju
AU  - Zhang X
AD  - Department of Respiratory and Critical Care Medicine, Henan Provincial People's 
      Hospital, Zhengzhou, China.
FAU - Zhang, Lei
AU  - Zhang L
AD  - Department of Endoscopy, Cancer Institute and Hospital, Chinese Academy of 
      Medical Sciences, Beijing, China.
FAU - Xie, Fangfang
AU  - Xie F
AD  - Department of Respiratory Endoscopy, Department of Respiratory and Critical Care 
      Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 
      China.
AD  - Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
FAU - Sun, Jiayuan
AU  - Sun J
AD  - Department of Respiratory Endoscopy, Department of Respiratory and Critical Care 
      Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 
      China.
AD  - Shanghai Engineering Research Center of Respiratory Endoscopy, Shanghai, China.
FAU - Li, Shiyue
AU  - Li S
AD  - State Key Laboratory of Respiratory Diseases, National Clinical Research Center 
      for Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First 
      Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04571476
PT  - Journal Article
PL  - China
TA  - J Thorac Dis
JT  - Journal of thoracic disease
JID - 101533916
PMC - PMC9186243
OTO - NOTNLM
OT  - Ultrathin bronchoscope (UTB)
OT  - endobronchial ultrasound (EBUS)
OT  - peripheral pulmonary lesions (PPLs)
OT  - thin bronchoscope (TB)
OT  - virtual bronchoscopic navigation (VBN)
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at 
      https://jtd.amegroups.com/article/view/10.21037/jtd-22-20/coif). All authors 
      report funding from Olympus (Beijing) sales and service Co., Ltd.
EDAT- 2022/06/14 06:00
MHDA- 2022/06/14 06:01
PMCR- 2022/05/01
CRDT- 2022/06/13 03:17
PHST- 2022/01/09 00:00 [received]
PHST- 2022/04/07 00:00 [accepted]
PHST- 2022/06/13 03:17 [entrez]
PHST- 2022/06/14 06:00 [pubmed]
PHST- 2022/06/14 06:01 [medline]
PHST- 2022/05/01 00:00 [pmc-release]
AID - jtd-14-05-1663 [pii]
AID - 10.21037/jtd-22-20 [doi]
PST - ppublish
SO  - J Thorac Dis. 2022 May;14(5):1663-1673. doi: 10.21037/jtd-22-20.