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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

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
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Nodule, Multiple

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    July 26, 2022
    Last Updated
    August 9, 2022
    Sponsor
    RenJi Hospital
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    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

    Learn more about this trial

    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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