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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided bronchoscopy | Device | It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
1) Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function
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Patients with peripheral pulmonary lesions that require histological differentiation because of the possibility of malignancy and are scheduled for biopsy attempted through guided bronchoscopy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeon Wook Kim, MD., PhD | Contact | +82-31-787-8134 | kimyw@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Yeon Wook Kim, MD., PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongsan Hospital Keimyung University School of Medicine | Recruiting | Daegu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30476574 | Background | 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. | |
| 26367186 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Confirmed by follow-up results at 1 year |
| Sensitivity for malignancy | True positive/Confirmed malignancy cases | Confirmed by follow-up results at 1 year |
| Complication | Evaluate complications due to guided bronchoscopic biopsy | Confirmed by follow-up results at 1 year |
| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Chunnam National University Hwasun Hospital | Recruiting | Hwasun | South Korea |
|
| Inje University Ilsan Paik Hospital | Recruiting | Ilsan | South Korea |
|
| Gyeongsang National University Hospital | Recruiting | Jinju | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | 13620 | South Korea |
|
| Asan Medical Center, University of Ulsan College of Medicine | Recruiting | Seoul | South Korea |
|
| Gangnam Severence Hospital | Recruiting | Seoul | South Korea |
|
| Hanyang University Hostpital | Recruiting | Seoul | South Korea |
|
| The Catholic University of Korea, Seoul, Korea | Recruiting | Seoul | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
|
| Background |
| 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. |
| 32450240 | Background | 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. |
| 34506792 | Background | 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. |
| 25590477 | Background | 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. |
| 37130440 | Background | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |