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The Diagnostic Value of Bronchoscopic Needle-based Confocal Laser Endomicroscopy (nCLE) As a Real-time Detection Tool for Diagnosing Peripheral Lung Cancer: a Multi-centre Randomised Controlled Trial

ConditionsLung Cancer, Non-Small CellLung Cancer, Small Cell
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChina-Japan Friendship Hospital

About this trial

The goal of this prospective, multi-centre, randomised controlled clinical study is to evaluate the diagnostic efficacy and safety of nCLE guided lung biopsy in patients with for peripheral lung nodules under the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS), and assess whether the biopsy techniques, namely transbronchial crybiopsy (TBCB) and transbronchial forceps biopsy (TBFB), would influence the diagnostic efficacy and safety of nCLE guided biopsy.

Participants will divided into nCLE-NB-rEBUS-forcep biopsy group, nCLE-NB-rEBUS-TBCB group, NB-rEBUS-forcep biopsy group, and NB-rEBUS-TBCB group at a 1:1:1:1 ratio by using central, computerized random sequence, and then undertake nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, and NB-rEBUS-TBCB according to the group.

Researchers will compare the diagnostic yield and incidence of adverse events of the four biopsy techniques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with peripheral lung nodules suspected of lung cancer based on CT scan (10mm≤size<30mm);

patients requiring diagnostic bronchoscopy procedure to determine the benign or malignant nature of the lung nodule;

Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Disqualifiers

Inability or non-willingness to provide informed consent;

Endobronchial visible malignancy on bronchoscopic inspection;

Target lesion within reach of the linear EBUS scope;

Failure to comply with the study protocol;

Trial design

Design model

Parallel

Treatments tested in this trial

  • nCLE-NB-rEBUS-forcep biopsy

    Procedure/Surgery

    The participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

  • nCLE-NB-rEBUS-TBCB

    Procedure/Surgery

    The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

  • NB-rEBUS-forcep biopsy

    Procedure/Surgery

    The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

  • NB-rEBUS-TBCB

    Procedure/Surgery

    The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

Treatment groups

1,040 Participants
are divided into 4 treatment groups
Group A: nCLE-NB-rEBUS-forcep biopsyExperimental treatment 1 intervention
Group B: nCLE-NB-rEBUS-TBCBExperimental treatment 1 intervention
Group C: NB-rEBUS-forcep biopsyActive comparator 1 intervention
Group D: NB-rEBUS-TBCBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS

The proportion of participants in whom the biopsy led to a definitive diagnosis.

Time frame
7 days after the biopsy
2

Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS

The proportion of participants of lung cancer in whom the biopsy led to a definitive diagnosis .

Time frame
7 days after the biopsy

Secondary outcomes

1

Incidence rate of adverse events

Symptoms and signs

Time frame
7 days after the biopsy
2

the adequacy of sample acquisition

Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.

Time frame
7 days after the biopsy

Other outcomes

Sponsors and contacts

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

China-Japan Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: