EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE
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
Shanghai Chest Hospital
162 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
Exclusion Criteria6
- Enlarged lymph nodes are identified as cystic or abscesses;
- Severe coagulopathy, insufficient anticoagulants/antiplatelets withdraw time or bleeding diathesis (platelets\<50\*109/L, INR\>1.3) that do not meet bronchoscopy requirements;
- Other contraindications to bronchoscopy or transbronchial biopsy, such as severe cardiopulmonary insufficiency, intolerance to anesthesia, or endoscopic procedures;
- Patients who have participated in another clinical trial within the past three months;
- Vulnerable groups, such as pregnant women
- Any other condition that the investigator considers inappropriate for participation in this study.
Interventions
Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
Participants with lymphadenopathy would receive EBUS-TTFB attempts to conduct diagnoses.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06913569