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

NCT07352176 · tracked via the Priya Life Science China tracker

Sponsor

Guangzhou Medical University

Phase

Not applicable

Started

2026-02-01

Last updated

2026-01-20

Condition(s) studied

Pulmonary LesionLung Cancer

Investigational drug(s) / intervention(s)

Confocal laser endomicroscopy combined cryobiopsyConventional cryobiopsy

Confocal laser endomicroscopy combined cryobiopsy: Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions.

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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients over 18 years old with lung lesions indicated by chest CT; 2. Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it; 3. Able to understand and voluntarily sign the written informed consent form. - Exclusion Criteria: 1. Patients with contraindications to anesthesia or bronchoscopy; 2. Patients with uncorrectable coagulation disorders; 3. Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery; 4. Patients with severe liver or kidney dysfunction, mental illness, etc.; 5. Pregnant or lactating patients; 6. Patients without a clear histological or clinical diagnosis; 7. Subjects deemed unsuitable for participation in this study by the investigator.

Primary outcome measure(s)

Incidence of adverse events — 7 days after procedure
The Incidence of adverse events = (the number of adverse event / the number of procedures) \* 100%

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163	Guangzhou	Guangdong

More Guangzhou Medical University trials in China

Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis Recruiting

Second-Generation Laryngeal Mask Airway vs Endotracheal Intubation in Adult Liver Transplantation Recruiting

Peri-operative Nutrition in Infants With Congenital Heart Disease Recruiting

Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis Active, not recruiting

CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment Recruiting

Other trials for the same condition

Research on Early Screening and Diagnosis of Pulmonary Nodules Based on Novel Non-invasive Technologies. Recruiting

Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy Recruiting

Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer Recruiting

Application of DCE-MRI Based on 4D FreeBreathing in Predicting the Efficacy of Immune and Targeted Therapy in Lung Cancer Recruiting

Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07352176 on ClinicalTrials.gov ↗ ← All trials in China