Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions
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: Confocal laser endomicroscopy combined cryobiopsy, Conventional cryobiopsy.
- Who it may be relevant to
- Registry conditions: Pulmonary Lesion, Lung Cancer. Basic parameters: from 18 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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Official title
Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions
Overview
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.
Interventions
- Other Confocal laser endomicroscopy combined cryobiopsy
Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions. - Other Conventional cryobiopsy
Patients in the conventional group will underg cryobiopsy for lung lesions.
Primary outcome measures
- Incidence of adverse events [Time frame: 7 days after procedure]
Secondary outcome measures (2)
- Diagnostic yield [Time frame: Immediately after the procedure]
- Hole-in-lesion rate [Time frame: During the procedure]
Eligibility criteria
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.
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
- The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163 — Guangzhou
Publications
- Kramer T, Wijmans L, de Bruin M, van Leeuwen T, Radonic T, Bonta P, Annema JT. Bronchoscopic needle-based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer. Thorax. 2022 Apr;77(4):370-377. doi: 10.1136/thoraxjnl-2021-216885. Epub 2021 Jun 25. PMID 34172559
- Wellikoff AS, Holladay RC, Downie GH, Chaudoir CS, Brandi L, Turbat-Herrera EA. Comparison of in vivo probe-based confocal laser endomicroscopy with histopathology in lung cancer: A move toward optical biopsy. Respirology. 2015 Aug;20(6):967-74. doi: 10.1111/resp.12578. Epub 2015 Jun 19. PMID 26094505
- Sorokina A, Danilevskaya O, Averyanov A, Zabozlaev F, Sazonov D, Yarmus L, Lee HJ. Comparative study of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics. Respirology. 2014 Aug;19(6):907-13. doi: 10.1111/resp.12326. Epub 2014 Jun 9. PMID 24909555
Identifiers
NCT: NCT07352176 · CLE-Cryo