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NCT Number: NCT07352176

Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions

Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.

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Key information

Conditions

Pulmonary Lesion Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Guangzhou, Guangdong, 510100, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years old with lung lesions indicated by chest CT;
  • Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;
  • Able to understand and voluntarily sign the written informed consent form. -

Exclusion criteria

  • Patients with contraindications to anesthesia or bronchoscopy;
  • Patients with uncorrectable coagulation disorders;
  • Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
  • Patients with severe liver or kidney dysfunction, mental illness, etc.;
  • Pregnant or lactating patients;
  • Patients without a clear histological or clinical diagnosis;
  • Subjects deemed unsuitable for participation in this study by the investigator.

Treatment and study plan

Confocal laser endomicroscopy combined cryobiopsy

Other

Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions.

Conventional cryobiopsy

Other

Patients in the conventional group will underg cryobiopsy for lung lesions.

Primary outcomes

  1. Incidence of adverse events

    Time frame: 7 days after procedure

    The Incidence of adverse events = (the number of adverse event / the number of procedures) * 100%

Secondary outcomes

  1. Diagnostic yield

    Time frame: Immediately after the procedure

    The diagnostic yield = (the number of successful diagnoses / the number of completed biopsies) * 100%

  2. Hole-in-lesion rate

    Time frame: During the procedure

    The rate of "hole-in-lesion" = (The number of cases with "hole-in-lesion" / The total number of cases that completed biopsy) * 100% The definition of "Hole-in-lesion": After cryobiopsy, a CBCT scan is performed, and the CBCT image shows the presence of a cavity within the lesion.

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Registry information

Official study title

Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

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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