Comparing two methods for diagnosing lymph node issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness and safety of endobronchial ultrasound-guided transtunnel forceps biopsy (EBUS-TTFB) with the standard transbronchial needle aspiration (EBUS-TBNA) for diagnosing inadequate lymph node specimens. It aims to address the limitations of EBUS-TBNA by using a single-use bronchoscopic puncture dilation catheter to create a tunnel for better tissue acquisition. The study is designed as a prospective, multicenter, randomized controlled trial involving 162 patients, with primary and secondary endpoints focusing on diagnostic yield and procedure safety. The goal is to establish the efficacy of EBUS-TTFB in a clinical setting where EBUS-TBNA may not provide sufficient tissue samples.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years;
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:

1. Enlarged lymph nodes are identified as cystic or abscesses;
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.

Where it's running

• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• The Fourth Affiliated Hospital of China Medical University
  Shenyang, Liaoning, China Not yet recruiting
• Huzhou Central Hospital
  Huizhou, Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Jiayuan Sun, MD, PhD
• Email: xkyyjysun@163.com
• Phone: +86-021-22200000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.