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NCT Number: NCT06741826

Confocal Laser Endomicroscopy Guided Cryobiopsy in the Diagnosis of Interstitial Lung Disease

A prospective multicenter randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of NCLE-NB-Rebus-guided peripheral pulmonary nodule biopsy, and to compare the diagnostic efficacy and safety of biopsy forceps biopsy and needle aspiration biopsy in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS.

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Key information

About this study

A prospective, multicenter, randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of nCLE-NB-rEBUS guided peripheral pulmonary nodule biopsy. Patients with peripheral pulmonary nodules suspected of lung cancer and pulmonary tuberculosis were enrolled to sign informed consent. Subjects were randomized to the nCLE-NB-rEBUS Group (Group A) or the NB-rEBUS Group (Group B) subgroup (1:1 ratio) according to the random number table, and subjects randomly assigned to Group A or Group B were again randomized to the biopsy forceps subgroup or biopsy needle subgroup by the random number table. The diagnostic efficacy and safety of the NCLE-NB-REbus group and the NB-rEBUS group were compared to evaluate whether nCLE could improve the diagnostic rate of NB-REbus-guided peripheral pulmonary nodule biopsy. The diagnostic efficacy and safety of using biopsy forceps and biopsy needle in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS were compared to determine the reasonable biopsy method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with peripheral pulmonary nodules suspected of lung cancer by CT examination
  • Patients who intend to undergo a bronchoscopic lung biopsy to determine benign or malignant pulmonary nodules;
  • Age ≥18 years
  • Sign informed consent.

Exclusion criteria

  • There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
  • Tumors can be seen in the bronchus
  • Hemodynamic instability;
  • Refractory hypoxemia;
  • Patients with pregnant and lactating patients
  • Any illness or condition that interferes with the completion of the initial or subsequent assessment.

Treatment and study plan

Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Procedure

Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Other names: Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy.

Primary outcomes

  1. Diagnostic rate of biopsy to obtain pathological diagnosis.

    Time frame: 6 months

    The biopsies obtained from the two groups were fixed in 10% formaldehyde and sent for pathological examination. The pathological diagnosis results were identified by two pathologists back to back, and the results were consistent, that is, confirmed. If the results are inconsistent, they will be identified by a third pathologist and finally determined by the three experts after discussion.

Secondary outcomes

  1. Occurrence of operation-related complications

    Time frame: 6 months

    7 days of follow-up data (including bleeding, infection, pain, fever, etc.). Patients who did not obtain a confirmed diagnosis were followed up to 6 months after surgery to evaluate their diagnosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Hou

CONTACT

[email protected]

13840065481

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

The Diagnostic Performance and Safety of Confocal Laser Endomicroscopy Guided Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease: a Randomised Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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