Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

Официальное название

Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

Обзор

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.

Подробное описание

* 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).

Вмешательства

• Устройство 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.

Первичные конечные точки

• Diagnostic yield at index [Срок оценки: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)]

Вторичные конечные точки (3)

• Diagnostic accuracy at 12 months [Срок оценки: Confirmed by follow-up results at 1 year]
• Sensitivity for malignancy [Срок оценки: Confirmed by follow-up results at 1 year]
• Complication [Срок оценки: Confirmed by follow-up results at 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 11 центров

• Dongsan Hospital Keimyung University School of Medicine — Daegu
• Hallym University Dongtan Sacred Heart Hospital — Gyeonggi-do
• Chunnam National University Hwasun Hospital — Hwasun
• Inje University Ilsan Paik Hospital — Ilsan
• Gyeongsang National University Hospital — Jinju
• Seoul National University Bundang Hospital — Seongnam-si
• Asan Medical Center, University of Ulsan College of Medicine — Seoul
• Gangnam Severence Hospital — Seoul
• … и ещё 3 центра

Публикации

• 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: PMID 30476574
• 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 A PMID 26367186
• 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. PMID 32450240
• 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. PMID 34506792
• 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. PMID 25590477
• 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. PMID 37130440

Идентификаторы

NCT: NCT05804786 · K-ORIENT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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