Endobronchial Ultrasound-Guided Transtunnel Forceps Biopsy vs. Transbronchial Needle Aspiration for Diagnosing Inadequate Lymph Node Specimens Based on Macroscopic On-site Evaluation: A Prospective, Randomized, Multicenter Study
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years;
• Chest imaging shows mediastinal or hilar lymphadenopathy (short axis ≥10 mm), requiring EBUS-TBNA for definitive diagnosis;
• EBUS-TBNA can be performed on these lymph nodes, and the specimens obtained from conventional EBUS-TBNA with three needle passes are inadequate (macroscopic visible core \< 30 mm);
• Willing to participate in this clinical study and sign the informed consent form.
Locations
Other Locations
China
Huzhou Central Hospital
NOT_YET_RECRUITING
Huizhou
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
The Fourth Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Contact Information
Primary
Jiayuan Sun, MD, PhD
xkyyjysun@163.com
+86-021-22200000
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 162
Treatments
Active_comparator: EBUS-TBNA
Specimens were obtained using a 22-gauge biopsy needle by bronchoscope. Each lymph node was operated 4 passes.
Experimental: EBUS-TTFB via a tunnel
A tunnel to reach the lymph node is established by making use of a puncture dilation catheter, and specimens were obtained using a 1.5 mm biopsy forceps by bronchoscope. Conduct biopsies until 5-10 specimens are obtained, and the actual number of passes and effective specimens should be recorded.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Chest Hospital