Comparing two methods for diagnosing lymph node issues

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

This study is testing a new method for taking tissue samples from lymph nodes to see if it works better and is safer than the standard method for people who need a diagnosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 3 sites (Shenyang, Liaoning and 2 other locations)
• Trial ID: NCT06913569 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with mediastinal or hilar lymphadenopathy requiring biopsy due to inadequate specimens from previous EBUS-TBNA.

Not a fit: Patients with cystic or abscessed lymph nodes, severe coagulopathy, or other contraindications to bronchoscopy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve diagnostic accuracy for patients with lymphadenopathy, leading to better treatment outcomes.

How similar studies have performed: While EBUS-TBNA is a well-established method, the use of EBUS-TTFB is relatively novel and has not been extensively tested in prospective randomized controlled trials.

Eligibility criteria

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 this trial is running

Shenyang, Liaoning and 2 other locations

• The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Huzhou Central Hospital — Huizhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jiayuan Sun, MD, PhD

Conditions Lymphadenopathy