Clinical trial NCT05477251: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Nodule, Multiple
Pulmonary Nodule, Solitary
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 3-year recurrence-free survival rate
timeFrame: 3 year after treatment
Secondary outcomes:
measure: Postoperative hospital stay
timeFrame: During hospitalization
measure: Total hospitalization expenses Total hospitalization expenses
timeFrame: During hospitalization
measure: Incidence of complications
timeFrame: Within 1 month after operation
Other outcomes:
Locations:
Study officials:
References: