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

NCT05477251 | Not Yet Recruiting

• 1 other identifier: KY2021-263-B
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Outcome Measures

Primary Outcomes (1)

• 3-year recurrence-free survival rate

  3-year recurrence-free survival rate

  3 year after treatment

Secondary Outcomes (3)

• Postoperative hospital stay

  During hospitalization

• Total hospitalization expenses Total hospitalization expenses

  During hospitalization

• Incidence of complications

  Within 1 month after operation

Study Arms (2)

microwave ablation

EXPERIMENTAL

Procedure: microwave ablation

lobectomy

ACTIVE COMPARATOR

Procedure: lobectomy

Interventions

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.

microwave ablation

lobectomy PROCEDURE

lobectomy for GGOs located in hilar regions

lobectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Neurosurgical Procedures

Central Study Contacts

Jiachang Chi, Deputy chief physician

CONTACT

13761871073; chijiachang@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2022

Record last verified: 2022-08