Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT05477251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-11
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055613', 'term': 'Multiple Pulmonary Nodules'}, {'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}], 'ancestors': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038481', 'term': 'Anterior Temporal Lobectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year recurrence-free survival rate', 'timeFrame': '3 year after treatment', 'description': '3-year recurrence-free survival rate'}], 'secondaryOutcomes': [{'measure': 'Postoperative hospital stay', 'timeFrame': 'During hospitalization', 'description': 'Postoperative hospital stay'}, {'measure': 'Total hospitalization expenses Total hospitalization expenses', 'timeFrame': 'During hospitalization', 'description': 'Total hospitalization expenses'}, {'measure': 'Incidence of complications', 'timeFrame': 'Within 1 month after operation', 'description': 'Incidence of complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Nodule, Multiple', 'Pulmonary Nodule, Solitary']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The age ranged from 18 to 75 years old, male or female;\n2. 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.\n3. The size of GGO lesions was 8mm-3cm, and the number of nodules was ≤ 3.\n4. There was no lymph node metastasis, intrapulmonary metastasis or distant organ metastasis;\n5. After multidisciplinary evaluation, the patients were feasible for lobectomy and CT guided microwave treatment;\n6. No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;\n7. Patients and /or family members agreed to join the clinical trial and signed informed consent.\n\nExclusion Criteria:\n\n1. 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;\n2. The lesions had received other treatments before; patients with regional lymph node metastasis or distant metastasis or with pleural fluid and ascites;\n3. Patients with poor compliance;\n4. Severe heart, lung, kidney, brain and other important organ diseases;\n5. The researcher believes that it is not suitable for inclusion'}, 'identificationModule': {'nctId': 'NCT05477251', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KY2021-263-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microwave ablation', 'interventionNames': ['Procedure: microwave ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lobectomy', 'interventionNames': ['Procedure: lobectomy']}], 'interventions': [{'name': 'microwave ablation', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['microwave ablation']}, {'name': 'lobectomy', 'type': 'PROCEDURE', 'description': 'lobectomy for GGOs located in hilar regions', 'armGroupLabels': ['lobectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiachang Chi, Deputy chief physician', 'role': 'CONTACT', 'email': 'chijiachang@aliyun.com', 'phone': '13761871073'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Chi Jiachang', 'investigatorAffiliation': 'RenJi Hospital'}}}}