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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphadenopathy
• Intervention / Treatment: Procedure: EBUS-TBNA; Procedure: EBUS-TTFB

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.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD, PhD; Phone Number: 1511 +86-021-22200000; Email: xkyyjysun@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110032
      • Not yet recruiting
      • The fourth Affiliated Hospital of China Medical University
      • Contact: Shitao Mao; Phone Number: +86 18900916056; Email: mst2012@sina.cn
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Jiayuan Sun, PhD; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com
  • Zhejiang
    • Huizhou, Zhejiang, China, 313000
      • Not yet recruiting
      • Huzhou Central Hospital
      • Contact: Te Zhang, B Med; Phone Number: +86 2555774; Email: 13857271121@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EBUS-TBNA; Specimens were obtained using a 22-gauge biopsy needle by bronchoscope. Each lymph node was operated 4 passes.	Procedure: EBUS-TBNA; Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
Experimental: 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.	Procedure: EBUS-TTFB; Participants with lymphadenopathy would receive EBUS-TTFB attempts to conduct diagnoses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	The diagnostic yield is defined as the proportion of lymph nodes diagnosed by each biopsy to the total number of lymph nodes enrolled in the study.	Six months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sample adequacy	The adequacy rate of samples for genetic testing: measured as the percentage of lymph node samples qualified for next-generation sequencing among all malignant lymph nodes.	Six months after the procedure
Tunnel creation success rate	Defined as the percentage of lymph nodes in the EBUS-TTFB group where successful tunneling was achieved among the total number of lymph nodes.	During the procedure
Total procedure time	The total procedure time is defined as the time from the insertion of the bronchoscope to its removal.	During the procedure
TTFB procedure time	The EBUS-TTFB procedure time is defined as the time from the insertion of the biopsy needle into the bronchoscope to the cessation of bleeding after the final TTFB.	During the procedure
TBNA procedure time	The EBUS-TBNA procedure time is defined as the time from the insertion of the biopsy needle into the bronchoscope to the cessation of bleeding after the final TBNA.	During the procedure
Incidence of complications	Including pneumothorax, infection, mediastinal hematoma, emphysema and etc.	Six months after the procedure

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Study Director: Jiayuan Sun, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: March 30, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: SHCHE202502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No