This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer. The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance.
The main questions this study aims to answer are:
1. Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas; 2. Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment; 3. Whether the robot-assisted Cryoablation method can reduce puncture time, ablation time and procedure time; 4. Whether the robot-assisted Cryoablation method can decrease the patient's complication occurrence rate; 5. Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance.
Participants suffering from lung cancer and judged by the investigator to be indicated for cryoablation procedures;
Participants voluntarily participate in this clinical study and sign the informed consent form;
Participants cannot undergo surgical treatment due to contraindications to surgical resection of lung cancer;
Participants can understand the study and cooperate with the study procedures, and are able to carry out follow-up observation as required.
Participants have diffuse lesions in both lungs that cannot be improved by ablative therapy;
Participants suffer from extensive pleural metastases with massive pleural effusion;
Participants have tumors adjacent to the mediastinal blood vessels, contrast allergy, or inability to cooperate, which makes it difficult to choose the route of needle insertion;
Participants with lesions encircling blood vessels where ablation may lead to severe bleeding;
Single group
CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation
Procedure/SurgeryDuring the procedure, the participants first undergo a CT scan. The radiologist plans the trajectories based on the registered preoperative CECT (contrast-enhanced computed tomography) and intraoperative CT. All participants then undergo navigation, localization, and establishment of cryoprobe trajectories using the interventional master-slave system. On the day of the procedure, the number of needle adjustments, number of cryoprobes used, puncture time, ablation time, and procedure time are recorded. The performance of the research device is evaluated by the radiologists. Postoperative complications of the participants are recorded 7±1 days postoperatively/on the day of discharge based on the postoperative CT scan (whichever comes first).
Technical success rate
After the cryoablation procedure, the radiologists evaluate the consistency of the postoperative ablation area derived from the immediate postoperative thoracic CT scan with the size of the preoperative planning area. If consistent, it is defined as a technical success. The technical success rate is defined as the ratio of the number of participants with technical success to the total number of enrolled participants.
The number of needle adjustments
The number will be counted when the needle tip angle is altered or the needle is retracted during the procedure.
Number of cryoprobes used
The number of cryoprobes used to complete cryoablation for a single target lesion during the cryoablation procedure.
Puncture time
Time from when the needle tip enters the skin to the completion of the puncture.
Ablation time
Time for the single lesion from when the cryoprobe arrives at the target to when the investigator judges the cryoablation is completed.
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Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Wuhan United Imaging Surgical co., ltd.
Collaborator
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