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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

NCT06739421 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2024-12-18

No results posted yet for this study

Summary

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.

Conditions

  • Lung Cancer, Non-Small Cell
  • Lung Cancer, Small Cell

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)

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06739421 on ClinicalTrials.gov