Back to resultsComparative Study on the Efficacy and Safety of Microwave Ablation and Lobectomy in the Treatment of Ground Glass Nodules Located in the Pulmonary Hilar Region
Primary Purpose
Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
microwave ablation
lobectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Nodule, Multiple
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
microwave ablation
lobectomy
Arm Description
Outcomes
Primary Outcome Measures
3-year recurrence-free survival rate
3-year recurrence-free survival rate
Secondary Outcome Measures
Postoperative hospital stay
Postoperative hospital stay
Total hospitalization expenses Total hospitalization expenses
Total hospitalization expenses
Incidence of complications
Incidence of complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05477251
Brief 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
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
microwave ablation
Arm Type
Experimental
Arm Title
lobectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
microwave ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
lobectomy
Intervention Description
lobectomy for GGOs located in hilar regions
Primary Outcome Measure Information:
Title
3-year recurrence-free survival rate
Description
3-year recurrence-free survival rate
Time Frame
3 year after treatment
Secondary Outcome Measure Information:
Title
Postoperative hospital stay
Description
Postoperative hospital stay
Time Frame
During hospitalization
Title
Total hospitalization expenses Total hospitalization expenses
Description
Total hospitalization expenses
Time Frame
During hospitalization
Title
Incidence of complications
Description
Incidence of complications
Time Frame
Within 1 month after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiachang Chi, Deputy chief physician
Phone
13761871073
Email
chijiachang@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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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
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