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

Launched by RENJI HOSPITAL · Jul 26, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for patients with ground glass nodules (GGNs) in a part of the lung called the pulmonary hilar region. Ground glass nodules can be an early sign of lung cancer, and the trial is comparing a newer treatment called microwave ablation (MWA) with a traditional surgery called lobectomy. Lobectomy involves removing a part of the lung, which can significantly affect lung function and quality of life. The trial is exploring whether microwave ablation, which is less invasive and may be safer, can effectively treat these nodules while minimizing complications like bleeding.

To participate in this study, individuals need to be between 18 and 75 years old and have been diagnosed with GGNs that have shown signs of growth or increased malignancy through imaging tests. They should have a specific size and number of nodules and must not have any spread of cancer to lymph nodes or other organs. Eligible participants will work closely with their healthcare team and give informed consent to join the trial. Throughout the study, participants will receive monitoring and care as researchers evaluate the effectiveness and safety of both treatment options.

Gender

ALL

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