The study aims to compare the efficacy and safety of endobronchial ultrasound-guided transtunnel forceps biopsy to transbronchial needle aspiration in diagnosing inadequate lymph node specimens based on macroscopic on-site evaluation.
Mediastinal and hilar lymphadenopathy are common clinical conditions. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the standard method recommended by guidelines for obtaining tissue from these patients. Endobronchial ultrasound-guided transbronchial forceps biopsy (EBUS-TBFB) can overcome the limitations of inadequate tissue acquisition with EBUS-TBNA, and its efficacy and safety have been proved. However, EBUS-TBFB often requires the assistance of the electrocautery for mediastinal window creation, which increases technical difficulty and requires electrosurgical equipment, making it unsuitable for application in grassroots hospitals. This study aims to use the endobronchial ultrasound-guided transtunnel forceps biopsy (EBUS-TTFB) method. A single-use bronchoscopic puncture dilation catheter will be employed to establish a tunnel between the airway and the lymph node, with both puncture and dilation completed in the same procedure. Currently, there is a lack of prospective randomized controlled trials to verify the efficacy and safety of EBUS-TTFB. This study is designed as a prospective, multicenter, randomized controlled trial. A total of 162 patients will be randomly allocated in a 1:1 ratio to the EBUS-TBNA group or the EBUS-TTFB group. The primary endpoint is thediagnostic yield. The secondary endpoints include specimen adequacy, procedure duration, tunnel creation success rate, and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
162
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
NOT_YET_RECRUITINGShanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGHuzhou Central Hospital
Huizhou, Zhejiang, China
NOT_YET_RECRUITINGDiagnostic yield
The diagnostic yield is defined as the proportion of lymph nodes diagnosed by each biopsy to the total number of lymph nodes enrolled in the study.
Time frame: Six months after the procedure
Sample adequacy
The adequacy rate of samples for genetic testing: measured as the percentage of lymph node samples qualified for next-generation sequencing among all malignant lymph nodes.
Time frame: Six months after the procedure
Total procedure time
The total procedure time is defined as the time from the insertion of the bronchoscope to its removal.
Time frame: During the procedure
TTFB procedure time
The EBUS-TTFB procedure time is defined as the time from the insertion of the biopsy needle into the bronchoscope to the cessation of bleeding after the final TTFB.
Time frame: During the procedure
TBNA procedure time
The EBUS-TBNA procedure time is defined as the time from the insertion of the biopsy needle into the bronchoscope to the cessation of bleeding after the final TBNA.
Time frame: During the procedure
Tunnel creation success rate
Defined as the percentage of lymph nodes in the EBUS-TTFB group where successful tunneling was achieved among the total number of lymph nodes.
Time frame: During the procedure
Incidence of complications
Including pneumothorax, infection, mediastinal hematoma, emphysema and etc.
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Time frame: Six months after the procedure