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

NCT06913569 | Recruiting DMC

• 1 other identifier: SHCHE202502
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Sample adequacy

  Six months after the procedure

• Total procedure time

  During the procedure

• TTFB procedure time

  During the procedure

• TBNA procedure time

  During the procedure

• Tunnel creation success rate

  During the procedure

Study Arms (2)

EBUS-TBNA

ACTIVE COMPARATOR

Specimens were obtained using a 22-gauge biopsy needle by bronchoscope. Each lymph node was operated 4 passes.

Procedure: EBUS-TBNA

EBUS-TTFB via a tunnel

EXPERIMENTAL

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

Interventions

EBUS-TBNA PROCEDURE

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

EBUS-TBNA

EBUS-TTFB PROCEDURE

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

EBUS-TTFB via a tunnel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (3)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110032, China

NOT YET RECRUITING

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Huzhou Central Hospital

Huizhou, Zhejiang, 313000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphadenopathy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

+86-021-22200000; xkyyjysun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)