Comparative Study on the Efficacy and Safety of Microwave Ablation and Lobectomy in the Treatment of Ground Glass Nodules Located in the Pulmonary Hilar Region

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Treatments: Procedure: lobectomy; Procedure: microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05477251

KY2021-263-B

Details and patient eligibility

About

GGO is a characteristic focus of early lung cancer. Due to the abundant peripheral blood vessels and bronchial tissues around the GGO lesions located in pulmonary hilar, only lobectomy could be used for the surgical treat of hilar GGO lesions which will make the significantly decline of the pulmonary function after surgery and affect the quality of life to a great extent. Our previous study has reported a new blunt-tip MWA electrode (MTC-3CA-II3, Vison Medical Inc.) for the treatment of GGO lesions. The blunt-tip MWA electrode could improve the safety of GGO ablation, significantly reduce the occurrence of bleeding and hemoptysis, which made it possible to ablate GGO in the hilar region safely. In this study, the blunt-tip MWA electrode was used in the treatment of patients with hilar GGO lesions, and the efficacy and safety of microwave ablation and lobectomy in the treatment of ground glass nodules located in the pulmonary hilar region were evaluated and compared.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age ranged from 18 to 75 years old, male or female;
2. GGO lesions in the hilar region were diagnosed by imaging examination (CT / PET-CT). During the follow-up of 6-12 months, the lesions increased by more than 2mm, the solid components increased, or there were obvious solid components, or the GGOs were judged to be highly malignant by imaging.
3. The size of GGO lesions was 8mm-3cm, and the number of nodules was ≤ 3.
4. There was no lymph node metastasis, intrapulmonary metastasis or distant organ metastasis;
5. After multidisciplinary evaluation, the patients were feasible for lobectomy and CT guided microwave treatment;
6. No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;
7. Patients and /or family members agreed to join the clinical trial and signed informed consent.

Exclusion criteria

1. The general condition of the patient is very poor, ECOG physical fitness score > 2, unable to tolerate lobectomy and MWA treatment, or has relevant contraindications;
2. The lesions had received other treatments before; patients with regional lymph node metastasis or distant metastasis or with pleural fluid and ascites;
3. Patients with poor compliance;
4. Severe heart, lung, kidney, brain and other important organ diseases;
5. The researcher believes that it is not suitable for inclusion

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

microwave ablation

Experimental group

Treatment:

Procedure: microwave ablation

lobectomy

Active Comparator group

Treatment:

Procedure: lobectomy