Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions
Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions
1 other identifier
observational
1,240
1 country
11
Brief Summary
The primary objective is To evaluate the usefulness and safety of advanced guided bronchoscopy for histological diagnosis of peripheral pulmonary lesions. The Secondary objective is to establish a strategy that can most effectively use endoscopes for early diagnosis of lung cancer in a real-world care environment by identifying patient/clinical/image/procedure-related characteristics that can optimize the practicality of emerging technologies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
May 10, 2024
May 1, 2024
4.3 years
March 27, 2023
May 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic yield at index
The proportion of pathologic results that leads to a specific malignant or benign
Upon reports of pathologic results (up to 2 weeks after bronchoscopy)
Secondary Outcomes (3)
Diagnostic accuracy at 12 months
Confirmed by follow-up results at 1 year
Sensitivity for malignancy
Confirmed by follow-up results at 1 year
Complication
Confirmed by follow-up results at 1 year
Study Arms (1)
single group
Patients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through guided bronchoscopy
Interventions
It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.
Eligibility Criteria
Patients with peripheral pulmonary lesions that require histological differentiation because of the possibility of malignancy and are scheduled for biopsy attempted through guided bronchoscopy
You may qualify if:
- Patients who agreed in writing to participate in this study
- Adult men and women over 19 years of age
- Patients who visited the hospital with lung lesions suspected of lung cancer and require a diagnostic biopsy
- Patients capable of biopsy through guided bronchoscopy
You may not qualify if:
- \) Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Dongsan Hospital Keimyung University School of Medicine
Daegu, South Korea
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
Chunnam National University Hwasun Hospital
Hwasun, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Gangnam Severence Hospital
Seoul, South Korea
Hanyang University Hostpital
Seoul, South Korea
The Catholic University of Korea, Seoul, Korea
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Related Publications (6)
Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, Murillo BA, LeMense GP, Minnich DJ, Bansal S, Ellis BQ, Mahajan AK, Gildea TR, Bechara RI, Sztejman E, Flandes J, Rickman OB, Benzaquen S, Hogarth DK, Linden PA, Wahidi MM, Mattingley JS, Hood KL, Lin H, Wolvers JJ, Khandhar SJ; NAVIGATE Study Investigators. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019 Mar;14(3):445-458. doi: 10.1016/j.jtho.2018.11.013. Epub 2018 Nov 23.
PMID: 30476574BACKGROUNDOst DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.
PMID: 26367186BACKGROUNDFolch EE, Labarca G, Ospina-Delgado D, Kheir F, Majid A, Khandhar SJ, Mehta HJ, Jantz MA, Fernandez-Bussy S. Sensitivity and Safety of Electromagnetic Navigation Bronchoscopy for Lung Cancer Diagnosis: Systematic Review and Meta-analysis. Chest. 2020 Oct;158(4):1753-1769. doi: 10.1016/j.chest.2020.05.534. Epub 2020 May 23.
PMID: 32450240BACKGROUNDVachani A, Maldonado F, Laxmanan B, Kalsekar I, Murgu S. The Impact of Alternative Approaches to Diagnostic Yield Calculation in Studies of Bronchoscopy. Chest. 2022 May;161(5):1426-1428. doi: 10.1016/j.chest.2021.08.074. Epub 2021 Sep 7. No abstract available.
PMID: 34506792BACKGROUNDBowling MR, Kohan MW, Walker P, Efird J, Ben Or S. The effect of general anesthesia versus intravenous sedation on diagnostic yield and success in electromagnetic navigation bronchoscopy. J Bronchology Interv Pulmonol. 2015 Jan;22(1):5-13. doi: 10.1097/LBR.0000000000000120.
PMID: 25590477BACKGROUNDKops SEP, Heus P, Korevaar DA, Damen JAA, Idema DL, Verhoeven RLJ, Annema JT, Hooft L, van der Heijden EHFM. Diagnostic yield and safety of navigation bronchoscopy: A systematic review and meta-analysis. Lung Cancer. 2023 Jun;180:107196. doi: 10.1016/j.lungcan.2023.107196. Epub 2023 Apr 19.
PMID: 37130440BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yeon Wook Kim, MD., PhD
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 7, 2023
Study Start
April 1, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
May 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share