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Search / Trial NCT06913569

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

Launched by SHANGHAI CHEST HOSPITAL · Mar 30, 2025

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to find out which method is better for diagnosing lymph node problems in the chest: endobronchial ultrasound-guided transtunnel forceps biopsy (EBUS-TTFB) or transbronchial needle aspiration (EBUS-TBNA). Both techniques help doctors take samples from lymph nodes that may be enlarged, but this study focuses on those cases where the samples taken by the traditional method weren't adequate for a clear diagnosis. If you are at least 18 years old and have certain types of enlarged lymph nodes that need further examination, you might be eligible to participate.

Participants in this study will undergo one of the biopsy methods to see which one provides better and safer results. It's important to note that individuals with certain health conditions, such as severe bleeding issues or those who have recently participated in another clinical trial, may not qualify for this study. If you join, you will need to sign a consent form, which means you agree to take part and understand what the study involves. This trial is currently recruiting participants, so if you or someone you know is facing these health issues, it could be an opportunity to contribute to valuable research that may improve future diagnosis methods.

Gender

ALL

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.

About Shanghai Chest Hospital

Shanghai Chest Hospital is a leading medical institution in China, renowned for its specialized expertise in respiratory and thoracic diseases. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical research and improving patient outcomes through innovative therapies and treatments. With a strong emphasis on collaboration and scientific rigor, Shanghai Chest Hospital actively engages in a variety of clinical trials aimed at exploring novel interventions and enhancing the understanding of pulmonary health. The hospital's state-of-the-art facilities and commitment to patient-centered care position it as a key player in the global research landscape.

Locations

Shenyang, Liaoning, China

Shanghai, Shanghai, China

Huizhou, Zhejiang, China

Patients applied

0 patients applied

Trial Officials

Jiayuan Sun

Study Director

Shanghai Chest Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported