Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-01 @ 4:12 PM
Study NCT ID:
NCT07065604
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tubeless VATS for Mediastinal Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008479', 'term': 'Mediastinal Neoplasms'}], 'ancestors': [{'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008477', 'term': 'Mediastinal Diseases'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion rate to open surgery', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'Proportion of patients requiring conversion from VATS to open surgery.'}, {'measure': 'Conversion rate to intubated anesthesia', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia'}, {'measure': 'Postoperative complication rate', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events.'}], 'secondaryOutcomes': [{'measure': 'R0 rate', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'R0 resection rate'}, {'measure': 'Operation time', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin).'}, {'measure': 'Intraoperative bleeding loss', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'The volume of bleeding during the surgery.'}, {'measure': 'ICU stay', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'ICU stay (in days), defined as the duration from ICU admission post-surgery to ICU discharge.'}, {'measure': 'Hospital stay', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'Hospital stay, defined as the duration from the day of surgery to the day of discharge.'}, {'measure': 'Volume of postoperative drainage', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'Volume of postoperative drainage, measured from the end of surgery until drain removal.'}, {'measure': '1-year disease-free survival (DFS)', 'timeFrame': '1 year after surgery', 'description': '1-year disease-free survival (DFS), defined as the percentage of patients alive without evidence of tumor recurrence or progression at 12 months.'}, {'measure': '1-year overall survival(OS)', 'timeFrame': '1 year after surgery', 'description': '1-year overall survival(OS), defined as the percentage of patients alive at 12 months from the date of surgery or treatment initiation, irrespective of disease recurrence or progression.'}, {'measure': 'Quality of life (QOL) at 3 month', 'timeFrame': 'Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.', 'description': '3 months after discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-intubated Anesthesia', 'Tubeless', 'Mediastinal Neoplasm', 'VATS'], 'conditions': ['Mediastinal Neoplasm', 'VATS', 'Tubeless', 'Non-intubated Anesthesia']}, 'descriptionModule': {'briefSummary': 'In recent year, non-intubated anesthesia had emerged as an available and promising alternative for thoracic procedure. However, its safety and feasibility in video-assisted thoracoscopic surgery (VATS) for mediastinal neoplasm remain controversial. This randomized controlled trial is designed to evaluate the impact of the non-intubated approach on surgical and perioperative outcomes in patients undergoing mediastinal neoplasm resection.', 'detailedDescription': 'Non-intubated anesthesia has gained widespread adoption in recent years, representing a significant advancement in both thoracic surgery and anesthetic practice. The surgical safety and feasibility of tubeless VATS for mediastinal neoplasm has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. Accordingly, this randomized controlled trial aims to evaluate whether the non-intubated approach provides comparable short-term and long-term outcomes to the conventional intubated technique in VATS for mediastinal neoplasm resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Mediastinal neoplasm was diagnosed by chest enhanced CT\n2. The patients with age ≥ 18 and ≤ 80 years old\n3. The patients whose tumor diameter was \\<6 cm\n4. ASA grade: I-III\n5. The patients should understand the research and sign the informed consent\n\nExclusion Criteria:\n\n1. Imaging examinations revealed that the tumor had invaded adjacent organs, with evidence of pleural or pericardial dissemination, as well as lymphatic and/or hematogenous metastases\n2. Patients with a confirmed history of congestive heart failure, poorly controlled angina despite medical therapy, electrocardiogram-confirmed myocardial infarction with transmural involvement, uncontrolled hypertension, clinically significant valvular heart disease, or high-risk arrhythmias not adequately managed\n3. Patients with concurrent active malignancies'}, 'identificationModule': {'nctId': 'NCT07065604', 'acronym': 'NOVA-02', 'briefTitle': 'Tubeless VATS for Mediastinal Neoplasm', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm', 'orgStudyIdInfo': {'id': 'ES-2025-074-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-intubated group', 'description': 'Patients received tubeless VATS for mediastinal neoplasm', 'interventionNames': ['Procedure: Non-intubated VATS for mediastinal neoplasm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intubated group', 'description': 'Patients received VATS mediastinal neoplasm resection under intubated general anesthesia.', 'interventionNames': ['Procedure: Intubated VATS for mediastinal neoplasm']}], 'interventions': [{'name': 'Non-intubated VATS for mediastinal neoplasm', 'type': 'PROCEDURE', 'description': 'Non-intubated VATS for mediastinal neoplasm', 'armGroupLabels': ['Non-intubated group']}, {'name': 'Intubated VATS for mediastinal neoplasm', 'type': 'PROCEDURE', 'description': 'Intubated VATS for mediastinal neoplasm', 'armGroupLabels': ['Intubated group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'the First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shuben Li, Deputy Director', 'role': 'CONTACT', 'email': '13500030280@163.com', 'phone': '86(020) 8306 2114'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shuben Li', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Director', 'investigatorFullName': 'Shuben Li', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}