Lung Cancer Clinical Trial
Official title:
Comparison and Synergistic Evaluation of Needle Aspiration and Forceps Biopsy for Diagnosis of Lung Lesions With Electromagnetic Navigation Bronchoscopy
Verified date | June 2024 |
Source | Seoul National University Bundang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized crossover study aimed to evaluate whether a multimodal biopsy strategy using both needle and forceps can provide additive benefits compared with a single device for diagnosing peripheral pulmonary lesions with electromagnetic navigation bronchoscopy under moderate sedation and assess the comparative yield and discordance between the two devices.
Status | Active, not recruiting |
Enrollment | 142 |
Est. completion date | November 13, 2024 |
Est. primary completion date | November 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with lung lesions with a possibility of malignancy and need tissue confirmation, which is eligible for ENB procedure under moderate sedation Exclusion Criteria: - Patients who disagree to participate |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
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
Gildea TR, Folch EE, Khandhar SJ, Pritchett MA, LeMense GP, Linden PA, Arenberg DA, Rickman OB, Mahajan AK, Singh J, Cicenia J, Mehta AC, Lin H, Mattingley JS; NAVIGATE Study Investigators. The Impact of Biopsy Tool Choice and Rapid On-Site Evaluation on Diagnostic Accuracy for Malignant Lesions in the Prospective: Multicenter NAVIGATE Study. J Bronchology Interv Pulmonol. 2021 Jul 1;28(3):174-183. doi: 10.1097/LBR.0000000000000740. — View Citation
Mondoni M, Sotgiu G, Bonifazi M, Dore S, Parazzini EM, Carlucci P, Gasparini S, Centanni S. Transbronchial needle aspiration in peripheral pulmonary lesions: a systematic review and meta-analysis. Eur Respir J. 2016 Jul;48(1):196-204. doi: 10.1183/13993003.00051-2016. Epub 2016 May 12. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conservative diagnostic accuracy at 12 months | ([True positive + True negative]/All biopsied performed) | Confirmed by follow-up results at 12 months | |
Secondary | Sensitivity of needle or forceps biopsy for diagnosis of malignancy | True positive/Confirmed malignancy cases | Confirmed by follow-up results at 12 months | |
Secondary | Diagnostic yield at index procedure | The proportion of pathologic results that leads to a specific malignant or benign diagnosis | At index procedure | |
Secondary | Duration of procedure | Total duration and time per sampling for needle and forceps biopsy | At index procedure |
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