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

ConditionLymphadenopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • EBUS-TBNA

    Procedure/Surgery

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

  • EBUS-TTFB

    Procedure/Surgery

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

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: EBUS-TBNAActive comparator 1 intervention
Group B: EBUS-TTFB via a tunnelExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Six months after the procedure

Secondary outcomes

1

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.

Time frame
Six months after the procedure
2

Total procedure time

The total procedure time is defined as the time from the insertion of the bronchoscope to its removal.

Time frame
During the procedure
3

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.

Time frame
During the procedure
4

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.

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Source ClinicalTrials.gov
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