Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

Lung Cancer Clinical Trial

Official title:

Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804786
• Other study ID #: K-ORIENT
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: May 2024
• Source: Seoul National University Bundang Hospital
• Contact: Yeon Wook Kim, MD., PhD
• Phone: +82-31-787-8134
• Email: kimyw[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1240
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Guided bronchoscopy
It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.

Locations

Country	Name	City	State
Korea, Republic of	Dongsan Hospital Keimyung University School of Medicine	Daegu
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Chunnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul
Korea, Republic of	Gangnam Severence Hospital	Seoul
Korea, Republic of	Hanyang University Hostpital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul, Korea	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic accuracy at 12 months	True positive + True negative (confirmed benign with follow-up of at least 1yr without progression) / Total procedures; Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives.; For pathologic results of a benign non-specific diagnosis and non-diagnostic results, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Based on definition scenarios, these results will be determined as true negatives or false negatives. Diagnostic yields based on different scenarios will be reported.	Confirmed by follow-up results at 1 year
Secondary	Sensitivity for malignancy	True positive/Confirmed malignancy cases	Confirmed by follow-up results at 1 year
Secondary	Complication	Evaluate complications due to guided bronchoscopic biopsy	Confirmed by follow-up results at 1 year