Confocal Laser Endomicroscopy, Cryoablation, Lung Cancer (Suspected or Confirmed), Robotic Bronchoscopy System
Conditions
Brief summary
Using RBS as the navigation and treatment platform, precisely navigate to the target lesion. Utilize r-EUBS and nCLE to identify the lesion, and when the confocal AI model recognizes the lesion as malignant, perform a biopsy. Subsequently, under the guidance of OBCT, carry out ablation treatment of the lesion.
Interventions
PROCEDUREAblation
Using RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer
Sponsors
Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years, male or female. * High-risk pulmonary nodule/tumor maximum diameter ≤3 cm. * Lesion judged suitable for bronchial navigation-guided diagnosis and treatment. * Ineligible for surgery or refuses surgery/radiotherapy; agrees to primary ablation therapy; provides written informed consent.
Exclusion criteria
* Diffuse bilateral lung lesions unresponsive to ablation. * Contraindication to bronchoscopy or inability to tolerate/cooperate with bronchoscopy. * Severe bleeding tendency or irreversible coagulopathy (PT \>18 s, PTA \<40%).Platelet count \<70×10⁹/L; anticoagulant/antiplatelet therapy discontinued \<1 week before ablation (except prophylactic low-molecular-weight heparin). * Severe pulmonary impairment (maximal voluntary ventilation \<40%). * Other metastatic tumors with widespread metastasis; life expectancy \<3 months. * Poor general condition: widespread metastasis, severe infection, high fever, infectious/radiation inflammation around the lesion, obvious cachexia, severe organ dysfunction, severe anemia, uncorrectable metabolic/nutritional disorders. * Eastern Cooperative Oncology Group (ECOG) performance status \>2. * Target lesion received radiotherapy within the past 6 months. * Active hepatitis B, active hepatitis C, known HIV-1/2 antibody positivity, or other active infections judged by the investigator to interfere with treatment. * History of epilepsy, psychosis, or cognitive impairment. * Pregnant/lactating females; males or females planning conception during the trial. * Other conditions deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integrated completion rate of detection, sampling and treatment | Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range) | Integrated completion rate of detection, sampling and treatment= (Number of cases with successful integrated detection, sampling and treatment / Total enrolled cases) × 100% Definition of integrated success: Under the guidance of the bronchial navigation and positioning system, the lesion is confirmed by radial endobronchial ultrasound (r-EBUS) or CBCT; imaging diagnosis is obtained via probe-based confocal laser endomicroscopy (pCLE); qualified tissue samples are successfully collected; and local treatment is completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic success rate | 3 days after procedure( when the pathological examination results are available) | Diagnostic success rate = (Number of cases with definite pathological diagnosis / Total enrolled cases) × 100% Definition of definite pathological diagnosis: Malignant lesions Specific benign lesions: tuberculosis, fungal infection, granulomatous lesions, organizing pneumonia, etc. |
Contacts
CONTACTChanghao Zhong
Outcome results
None listed