5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies

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• Lung Neoplasms 7,233

Study arms

• Experimental
  Patients with pulmonary malignancies

  15 patients with pulmonary malignancies who meet the inclusion and exclusion criteria will be prospectively enrolled. 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation will be performed to treat the lesions.

  Procedure: 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation

Interventions

• Procedure5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation

  All procedures will be performed under general anesthesia with endotracheal intubation. The operator will remotely manipulate the control console to navigate the robotic bronchoscope to the target bronchus. For lesions with no ideal bronchial access, a tunnel to the target lesion will be established by needle puncture. Radial endobronchial ultrasound (rEBUS) may be selectively used to identify and confirm the lesion location. The cryoablation probe will be advanced into the lesion through the bronchus or the established tunnel. After confirming the position of the cryoablation probe using cone-beam computed tomography (CBCT), cryoablation will be performed. Immediately after cryoablation, CBCT will be performed to evaluate the spatial relationship between the ablation zone and the target lesion. An imaging safety margin extending at least 5 mm beyond the margin of the target lesion will serve as an important criterion for technical success.

Primary outcomes

1. Technical Success Rate (Lesion Level)

   The proportion of lesions achieving effective ablation under 5G-enabled remote robotic-assisted bronchoscopy guidance among all lesions that undergo ablation. Effective ablation is defined as an immediate post-procedural imaging finding demonstrating an ablation zone extending at least 5 mm beyond the margin of the target lesion.

   Time frame: Immediately after procedure

Secondary outcomes

1. Complete Ablation Rate at 6 Months (Lesion Level)

   The proportion of lesions that maintain complete ablation at 6 months after transbronchial cryoablation among all lesions that undergo ablation.

   Time frame: 6 months

2. Complete Ablation Rate at 12 Months (Lesion Level)

   The proportion of lesions that maintain complete ablation at 12 months after transbronchial cryoablation among all lesions that undergo ablation.

   Time frame: 12 months

3. Intrapulmonary Progression-Free Survival Rate at 6 Months (Patient Level)

   The proportion of patients without intrapulmonary disease progression at 6 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.

   Time frame: 6 months

4. Intrapulmonary Progression-Free Survival Rate at 12 Months (Patient Level)

   The proportion of patients without intrapulmonary disease progression at 12 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.

   Time frame: 12 months

5. Overall Survival Rate at 12 Months (Patient Level)

   The proportion of patients who remain alive at 12 months after transbronchial cryoablation among all patients who undergo ablation.

   Time frame: 12 months

6. Remote Image Transmission Latency

   Remote image transmission latency is defined as the sum of local image latency, network transmission latency, and image encoding/decoding latency.

   Time frame: Immediately after procedure

7. Remote Control Latency

   Remote control latency is defined as the sum of control computation latency, mechanical response latency, and network transmission latency.

   Time frame: Immediately after procedure

8. Packet Loss Rate

   Packet loss rate is calculated as the number of lost data packets divided by the total number of data packets transmitted by the sender.

   Time frame: Immediately after procedure

9. Safety (Patient Level)

   The incidence of device- or ablation-related adverse events occurring intraoperatively or within 1 month after the procedure.

   Time frame: 1 month