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Recruiting NCT06913569

EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE

No phase Interventional Lymphadenopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EBUS-TBNA, EBUS-TTFB.
Who it may be relevant to
Registry conditions: Lymphadenopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 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.

Interventions

  • Procedure EBUS-TBNA
    Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
  • Procedure EBUS-TTFB
    Participants with lymphadenopathy would receive EBUS-TTFB attempts to conduct diagnoses.

Primary outcome measures

  • Diagnostic yield [Time frame: Six months after the procedure]
Secondary outcome measures (6)
  • Sample adequacy [Time frame: Six months after the procedure]
  • Total procedure time [Time frame: During the procedure]
  • TTFB procedure time [Time frame: During the procedure]
  • TBNA procedure time [Time frame: During the procedure]
  • Tunnel creation success rate [Time frame: During the procedure]
  • Incidence of complications [Time frame: Six months after the procedure]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 3 centers
  • The Fourth Affiliated Hospital of China Medical University — Shenyang
  • Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
  • Huzhou Central Hospital — Huizhou

Identifiers

NCT: NCT06913569 · SHCHE202502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗