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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

The age ranged from 18 to 75 years old, male or female;

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.

The size of GGO lesions was 8mm-3cm, and the number of nodules was ≤ 3.

There was no lymph node metastasis, intrapulmonary metastasis or distant organ metastasis;

Disqualifiers

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;

The lesions had received other treatments before; patients with regional lymph node metastasis or distant metastasis or with pleural fluid and ascites;

Patients with poor compliance;

Severe heart, lung, kidney, brain and other important organ diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • microwave ablation

    Procedure/Surgery

    MWA procedures were performed under local anesthesia and CT guidance (GE Discovery CT750 HD) was used for the guidance. Using the coaxial system, MWA was performed by the combining of a 17G sharp-tip guide trocar needle and a 15-cm cooled-shaft electrode (18-gauge) with a 1.5-cm expandable blunt-tip (MTC-3CA-II3, Vison Medical Inc.). Firstly, the sharp-tip guide trocar needle was used to puncture through the pleura and then the blunt-tip MWA electrode was advanced into the GGO lesion through the guide needle lumen. Once the target was reached, ablation was performed at a power of 40 watts. Once the lesion was covered by the ablation zone, the ablation completed.

  • lobectomy

    Procedure/Surgery

    lobectomy for GGOs located in hilar regions

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: microwave ablationExperimental treatment 1 intervention
Group B: lobectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3-year recurrence-free survival rate

3-year recurrence-free survival rate

Time frame
3 year after treatment

Secondary outcomes

1

Postoperative hospital stay

Postoperative hospital stay

Time frame
During hospitalization
2

Total hospitalization expenses Total hospitalization expenses

Total hospitalization expenses

Time frame
During hospitalization
3

Incidence of complications

Incidence of complications

Time frame
Within 1 month after operation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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