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NCT Number: 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

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.

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Key information

Conditions

Pulmonary Nodule, Multiple Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Pulmonary Nodule, Solitary Respiratory Tract Diseases Respiratory Tract Neoplasms Solitary Pulmonary Nodule Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • After multidisciplinary evaluation, the patients were feasible for lobectomy and CT guided microwave treatment;
  • No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;
  • Patients and /or family members agreed to join the clinical trial and signed informed consent.

Exclusion criteria

  • 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;
  • The researcher believes that it is not suitable for inclusion

Treatment and study plan

Microwave ablation

Procedure

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

lobectomy for GGOs located in hilar regions

Primary outcomes

  1. 3-year recurrence-free survival rate

    Time frame: 3 year after treatment

    3-year recurrence-free survival rate

Secondary outcomes

  1. Postoperative hospital stay

    Time frame: During hospitalization

    Postoperative hospital stay

  2. Total hospitalization expenses Total hospitalization expenses

    Time frame: During hospitalization

    Total hospitalization expenses

  3. Incidence of complications

    Time frame: Within 1 month after operation

    Incidence of complications

Study contacts

Contact information is provided by the study sponsor or research team.

Jiachang Chi, Deputy chief physician

CONTACT

[email protected]

13761871073

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2022
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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