Status:
RECRUITING
EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Lymphadenopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Mediastinal and hilar lymphadenopathy are common clinical conditions. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the standard method recommended by guidelines for ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06913569
Start Date
April 1 2025
End Date
January 1 2026
Last Update
April 18 2025
Active Locations (3)
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1
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110032
2
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
3
Huzhou Central Hospital
Huizhou, Zhejiang, China, 313000