Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-17 @ 8:57 PM
Study NCT ID:
NCT06574295
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HTA of NIVATS Based on RWE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported Outcomes', 'timeFrame': 'Measured within 3 days post-surgery', 'description': "The primary outcome will be assessed using two validated instruments: the Anderson Symptom Inventory (lung cancer-specific module) and the EQ-5D. The Anderson Symptom Inventory will measure symptom severity (e.g., pain, fatigue, nausea, sleep disturbance) and the impact of symptoms on daily functioning, while the EQ-5D will evaluate overall health-related quality of life, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores will provide insight into patients' recovery and well-being following non-intubated video-assisted thoracic surgery (VATS) compared to traditional intubated thoracic surgery."}, {'measure': 'Postoperative hospitalization time', 'timeFrame': 'Measured in days from surgery completion to hospital discharge.', 'description': "The secondary outcome will measure the duration of the postoperative hospital stay. This will be assessed as the number of days from the completion of surgery to the patient's discharge. The goal is to compare the efficiency of recovery between patients undergoing non-intubated video-assisted thoracic surgery (VATS) and those receiving traditional intubated thoracic surgery."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer; Pulmonary nodule; VATs'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Traditional treatments like thoracotomy are highly invasive, while conventional thoracoscopic surgery can induce anesthesia-related complications. Non-intubated VATS offers a promising alternative by avoiding intubation and mechanical ventilation, thus reducing complications, anesthesia burden, and recovery time.\n\nThe study aims to comprehensively assess the clinical effectiveness, safety, and economic viability of non-intubated VATS for lung cancer treatment through systematic literature reviews, real-world evidence (RWE), and cost-effectiveness analysis. The research will also explore patient preferences using discrete choice experiments (DCE).\n\nBy evaluating this technology from a Chinese perspective, the study seeks to provide evidence-based recommendations for the broader adoption of non-intubated VATS in clinical settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients aged 18 to 75 years who have been diagnosed with pulmonary nodules or lung cancer and are scheduled for minimally invasive thoracic surgery. These patients will be divided into two groups: an experimental group undergoing non-intubated video-assisted thoracic surgery (VATS) and a control group undergoing intubated VATS. Both groups include individuals who are able to tolerate surgery based on preoperative evaluations, regardless of gender. All participants must provide informed consent and agree to complete the required follow-up assessments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：\n\n1. Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).\n2. Aged between 18 and 75 years, regardless of gender.\n3. Preoperative assessment indicates that the patient can tolerate non-intubated video-assisted thoracic surgery.\n4. The patient has signed an informed consent form and voluntarily agrees to participate in the study.\n\nControl Group (Intubated Video-assisted Thoracic Surgery)：\n\n1. Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).\n2. Aged between 18 and 75 years, regardless of gender.\n3. Preoperative assessment indicates that the patient can tolerate minimally invasive surgery.\n4. The patient has signed an informed consent form and voluntarily agrees to participate in the study.\n\nExclusion Criteria:\n\n1. Patients unable to provide sufficient preoperative and postoperative follow-up data.\n2. Pregnant or breastfeeding women.\n3. Patients with severe cardiopulmonary dysfunction preoperatively, making them unfit for surgery.\n4. Patients who have previously undergone surgery or radiotherapy in the same chest region.\n5. Patients with active infections or other severe comorbidities that may affect surgical outcomes.\n6. Patients with mental illness or cognitive impairment who cannot understand the study content or comply with follow-up requirements.'}, 'identificationModule': {'nctId': 'NCT06574295', 'briefTitle': 'HTA of NIVATS Based on RWE', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Health Technology Assessment of Pulmonary Nodules Using Non-intubated Video-assisted Thoracic Surgery Based on the Real-world Evidence', 'orgStudyIdInfo': {'id': 'FudanU-2024-07-1145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-intubated Video-assisted Thoracic Surgery Group', 'description': 'This group will undergo non-intubated video-assisted thoracic surgery (VATS), a minimally invasive procedure that avoids the use of endotracheal intubation and mechanical ventilation. Instead, patients maintain spontaneous breathing throughout the surgery under regional anesthesia or sedation. The technique is designed to reduce anesthesia-related complications, improve recovery times, and enhance overall patient comfort compared to traditional intubated thoracic surgeries.'}, {'label': 'Intubated Thoracic Surgery Group', 'description': 'This group will undergo traditional intubated thoracic surgery, where patients are intubated and placed on mechanical ventilation under general anesthesia. This method is commonly used in thoracic surgeries to control the airway and ensure adequate ventilation during the procedure. However, it may be associated with a higher incidence of anesthesia-related complications, such as airway trauma and slower postoperative recovery, compared to non-intubated techniques.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingyao Chen, PhD', 'role': 'CONTACT', 'email': 'yychen@shmu.edu.cn', 'phone': '8613564508981'}], 'facility': 'School of Public Health, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yingyao Chen, PhD', 'role': 'CONTACT', 'email': 'yychen@shmu.edu.cn', 'phone': '8613564508981'}], 'overallOfficials': [{'name': 'Yingyao Chen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'School of Public Health，Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yingyao Chen', 'investigatorAffiliation': 'Fudan University'}}}}