One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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%).

Trial design

Design model

Single group

Treatments tested in this trial

  • Ablation

    Procedure/Surgery

    Using RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: One-stop groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Integrated completion rate of detection, sampling and treatment

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.

Time frame
Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)

Secondary outcomes

1

Diagnostic success rate

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.

Time frame
3 days after procedure( when the pathological examination results are available)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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