EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE
NCT ID: NCT06913569
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
162 participants
INTERVENTIONAL
2025-04-01
2026-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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EBUS-TBNA
Specimens were obtained using a 22-gauge biopsy needle by bronchoscope. Each lymph node was operated 4 passes.
EBUS-TBNA
Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
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.
EBUS-TTFB
Participants with lymphadenopathy would receive EBUS-TTFB attempts to conduct diagnoses.
Interventions
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EBUS-TBNA
Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
EBUS-TTFB
Participants with lymphadenopathy would receive EBUS-TTFB attempts to conduct diagnoses.
Eligibility Criteria
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Inclusion Criteria
2. Chest imaging shows mediastinal or hilar lymphadenopathy (short axis ≥10 mm), requiring EBUS-TBNA for definitive diagnosis;
3. 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);
4. Willing to participate in this clinical study and sign the informed consent form.
Exclusion Criteria
2. Severe coagulopathy, insufficient anticoagulants/antiplatelets withdraw time or bleeding diathesis (platelets\<50\*109/L, INR\>1.3) that do not meet bronchoscopy requirements;
3. Other contraindications to bronchoscopy or transbronchial biopsy, such as severe cardiopulmonary insufficiency, intolerance to anesthesia, or endoscopic procedures;
4. Patients who have participated in another clinical trial within the past three months;
5. Vulnerable groups, such as pregnant women
6. Any other condition that the investigator considers inappropriate for participation in this study.
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Jiayuan Sun
Director, Department of Respiratory Endoscopy
Principal Investigators
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Jiayuan Sun
Role: STUDY_DIRECTOR
Shanghai Chest Hospital
Locations
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The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Huzhou Central Hospital
Huizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHCHE202502
Identifier Type: -
Identifier Source: org_study_id
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