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Not yet recruiting NCT06739421

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

No phase Interventional Lung Cancer, Non-Small Cell Lung Cancer, Small Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, NB-rEBUS-TBCB.
Who it may be relevant to
Registry conditions: Lung Cancer, Non-Small Cell, Lung Cancer, Small Cell. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure nCLE-NB-rEBUS-forcep biopsy
    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)
  • Procedure nCLE-NB-rEBUS-TBCB
    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)
  • Procedure NB-rEBUS-forcep biopsy
    The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
  • Procedure NB-rEBUS-TBCB
    The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

Primary outcome measures

  • diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS [Time frame: 7 days after the biopsy]
  • Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS [Time frame: 7 days after the biopsy]
Secondary outcome measures (2)
  • Incidence rate of adverse events [Time frame: 7 days after the biopsy]
  • the adequacy of sample acquisition [Time frame: 7 days after the biopsy]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Known allergy or risk factors for an allergic reaction to fluorescein;
  • Pregnancy or breast feeding;
  • Haemodynamic instability;
  • Refractory hypoxaemia;
  • Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure;
  • Unable to tolerate general anaesthesia according to the anaesthesiologist;
  • Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (eg, doxorubicin).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 1 center
  • China-Japan Friendship Hospital, , 100029 — Beijing

Identifiers

NCT: NCT06739421 · 2022YFC2404404-PN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗