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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple
• Intervention / Treatment: Procedure: microwave ablation; Procedure: lobectomy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiachang Chi, Deputy chief physician; Phone Number: 13761871073; Email: chijiachang@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: microwave ablation	Procedure: microwave ablation; 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.
ACTIVE_COMPARATOR: lobectomy	Procedure: lobectomy; lobectomy for GGOs located in hilar regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year recurrence-free survival rate	3-year recurrence-free survival rate	3 year after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hospital stay	Postoperative hospital stay	During hospitalization
Total hospitalization expenses Total hospitalization expenses	Total hospitalization expenses	During hospitalization
Incidence of complications	Incidence of complications	Within 1 month after operation

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2026
• Study Completion (ANTICIPATED): December 31, 2026

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (ACTUAL): July 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: KY2021-263-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No