Clinical trial NCT05804786: Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions
Official title: Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Electromagnetic Navigation Bronchoscopy
Guided Bronchoscopy
Diagnosis
Radial Endobronchial Ultrasound
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 1240
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral pulmonary lesions that require histological differentiation because of the possibility of malignancy and are scheduled for biopsy attempted through guided bronchoscopy

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.

Detailed description: * Patients with peripheral pulmonary lesions who need histological diagnosis due to suspected lung cancer and whose lesions are judged capable of histological examination through guided bronchoscopy will be prospectively recruited.
* This study is a pure non-interventional pragmatic design. In addition to biopsy for lung lesions using bronchoscopy, lung cancer staging and tests necessary for metastases and treatment for diagnosed lung cancer are performed according to existing guidelines and the judgment of medical staff.
* We will analyze the clinical characteristics of guided bronchoscopy procedures used in clinical practice and the main results during the follow-up period of up to one year (diagnostic yield, sensitivity, safety, practicality, and various factors affecting usefulness).

Eligibility criteria: Inclusion Criteria:

1. Patients who agreed in writing to participate in this study
2. Adult men and women over 19 years of age
3. Patients who visited the hospital with lung lesions suspected of lung cancer and require a diagnostic biopsy
4. Patients capable of biopsy through guided bronchoscopy

Exclusion Criteria:

1) Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function

Primary outcomes:
measure: Diagnostic yield at index
timeFrame: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)
Secondary outcomes:
measure: Diagnostic accuracy at 12 months
timeFrame: Confirmed by follow-up results at 1 year
measure: Sensitivity for malignancy
timeFrame: Confirmed by follow-up results at 1 year
measure: Complication
timeFrame: Confirmed by follow-up results at 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Dongsan Hospital Keimyung University School of Medicine
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Hwasun
country: Korea, Republic of
facility: Chunnam National University Hwasun Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Gangnam Severence Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hostpital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul, Korea
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Yeon Wook Kim, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ost 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.
citation: Folch 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.
citation: Vachani 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.
citation: Bowling 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.
citation: Kops 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.