Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nodules With Ground-glass Opacity

Fujian Medical University (FJMU)

Status: Not yet enrolling

Conditions: Ground-glass Opacity; Pulmonary Nodules

Treatments: Procedure: CT scan; Procedure: Robot

Study type: Interventional

Funder types: Other

Identifiers

NCT07389889

union TC1

Details and patient eligibility

About

1. To compare the precision of robot-guided microwave ablation and CT-guided microwave ablation in the treatment of ground-glass nodules.
2. To evaluate the safety of robot-assisted microwave ablation and CT-guided microwave ablation in the treatment of ground-glass nodules.
3. Explore the application potential of robot navigation microwave ablation technology in the treatment of pulmonary nodules.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 to 85 years

2. Nodules measuring 3-30mm with ground-glass opacities constituting ≥75% of the lesion

3. Preoperative clinical evaluation confirming no hilar or mediastinal lymph node metastasis and no distant metastasis

4. Patients diagnosed as stage IA primary peripheral lung cancer according to the UICC 8th TNM staging system, and with one of the following conditions:

   (i) cannot undergo surgical resection due to poor cardiopulmonary function or advanced age (ii) refusing or unwilling to undergo surgical resection (iii) with newly developed or residual pulmonary nodules after early-stage primary lung cancer surgery (iv) with unilateral lung disease who cannot undergo unilateral surgical resection (v)with multiple primary lung cancers unsuitable for surgical resection

5. Preoperative ECOG physical status score is 0/1

6. ASA score is I-III

7. Patients voluntarily participate in this study and sign the informed consent form

Exclusion criteria

1. Smoking cessation duration <2 weeks
2. Lesions adjacent to pulmonary artery-vein main trunks
3. Lesions near the hilum or adjacent to lobar bronchi
4. Pregnancy or lactation status
5. Severe mental disorders
6. History of other malignancies within 5 years
7. Unstable angina or myocardial infarction within 6 months with coronary angiography showing severe stenosis of major coronary branches
8. Cerebral infarction or hemorrhage within 6 months
9. Continuous systemic corticosteroid therapy within 1 month
10. Patients or their authorized persons who do not wish to comply with the study protocol
11. Patients with other investigator-assessed ineligibility for the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Group A: Experimental group: Microwave ablation under robot navigation

Active Comparator group

Description:

Microwave ablation under robot navigation

Treatment:

Procedure: Robot

Group B: CT-guided microwave ablation

Sham Comparator group

Treatment:

Procedure: CT scan