Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059379) titled 'Evaluation of the Usefulness of Continuous Positive Airway Pressure (CPAP) during EBUS-GS Guided Transbronchial Biopsy for Pulmonary Lesions' on Oct. 14.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - Peripheral lung lesion Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Diagnostic yield of bronchoscopic biopsy under CPAP for peripheral pulmonary lesions. Basic objectives2 - Others

Intervention: Interventions/Control_1 - We are planning to use continuous positive airway pressure (CPAP) to keep the airways open during bronchoscopy, in order to improve lesion access and increase the diagnostic yield for small peripheral lung lesions.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Patients who visit Fujita Health University Hospital and require a pathological diagnosis by bronchoscopy for a pulmonary nodule or opacity that meets all of the following criteria: Patients who have received a full explanation about this study, fully understood the contents, and have provided written informed consent of their own free will. Patients aged 20 years or older and younger than 90 years at the time of consent. Patients with a target lesion less than or equal to 2 cm in the longest diameter on chest CT. Patients who have undergone thin-slice chest CT (slice thickness less than 2 mm) prior to bronchoscopy. Key exclusion criteria - Patients with an evident pneumothorax prior to the procedure. Patients with respiratory failure (PaO2 less than 60 torr). Patients whose systolic blood pressure is below 80 mmHg immediately before the start of bronchoscopy. Any other patients judged to be inappropriate for inclusion by the principal investigator or sub-investigators. Target Size - 85

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 03 Month 24 Day Date of IRB - 2024 Year 03 Month 26 Day Anticipated trial start date - 2024 Year 04 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067912

Disclaimer: Curated by HT Syndication.