Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-04 @ 12:40 PM
Study NCT ID:
NCT03523468
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2018-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-05-02', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '6 months', 'description': 'visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'EORTC QLQ-C43 questionnaire is used.'}], 'secondaryOutcomes': [{'measure': '5 year survival', 'timeFrame': '5 years', 'description': 'follow up for 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VATS', 'Lung Cancer'], 'conditions': ['Video-Assisted Thoracic Surgery', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'In surgical treatment decisions, locally advanced central lung cancer is the most difficult. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment.Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies the surgical principle and is worthy of clinical promotion.this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation.', 'detailedDescription': "In surgical treatment decisions, locally advanced central lung cancer is the most difficult. Locally advanced central lung cancer refers to tumors that have recidivised adjacent organs and tissues, such as the esophagus, tracheal carina, pericardium, heart, large vessels, etc., with mediastinal lymph node metastases, but no distant metastases (such as bone) have been found by current examination methods. Adjacent hilar lymph nodes and blood vessels are easily invaded, so it is difficult to perform surgery and the resection rate is low. On the other hand, central lung cancer involving the opening of the main bronchus and upper lobe often requires pneumonectomy which would affect the quality of life. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment. The accepted principle of surgery is to maximize the removal of tumor tissue and to maximize the retention of healthy lung tissue. Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies this surgical principle and is worthy of clinical promotion.\n\npatients who are suitable for sleeve resection account for 5% to 13% of the total surgical volume. This also expands the indications for Video assisted thoracoscopic surgery (VATS). Some central lung cancer patients therefore could benefit from that, especially for elderly patients with poor cardiopulmonary function. However, central lung cancer sleeve resection performed by uniportal VATS is seldom reported, and it has been considered as a difficult and high-risk surgical method.\n\nThe Investigators' hospital has completed more than 300 cases of uniportal sleeve surgery, which has become the largest center for performing sleeve-surgery by uniportal VATS in the world.\n\nTherefore, this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation. The Investigators' work would promote the usage of uniportal-sleeve lobectomy in the treatment of patients with locally advanced central lung cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The tumor is located in the opening of bronchus, or the edge of the tumor is \\<2 cm away from the opening of the bronchi;\n2. The distance between the edge of the tumor and the carina is \\>1.5 cm;\n3. Partial benign lesions or the presence of bronchial stenosis Patient.\n\nExclusion Criteria:\n\n1. Distant metastasis;\n2. Cardiopulmonary function cannot tolerate surgery.'}, 'identificationModule': {'nctId': 'NCT03523468', 'briefTitle': 'Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pulmonary Hospital, Shanghai, China'}, 'officialTitle': 'Curative Effect and Quality of Life Between Uniportal Sleeve Lobectomy and Open-chest Sleeve Lobectomy for Central Type Lung Cancer: a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'jianglei3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'uniportal sleeve lobectomy', 'description': 'locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy', 'interventionNames': ['Procedure: uniportal sleeve lobectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'open sleeve lobectomy', 'description': 'locally advanced central lung cancer resection by open chest sleeve lobectomy', 'interventionNames': ['Procedure: open sleeve lobectomy']}], 'interventions': [{'name': 'uniportal sleeve lobectomy', 'type': 'PROCEDURE', 'description': 'central lung cancer sleeve resection performed by uniportal VATS', 'armGroupLabels': ['uniportal sleeve lobectomy']}, {'name': 'open sleeve lobectomy', 'type': 'PROCEDURE', 'description': 'central lung cancer sleeve resection performed by open chest', 'armGroupLabels': ['open sleeve lobectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200020', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jian chen, doctor', 'role': 'CONTACT', 'email': 'yufuchenjian@163.com', 'phone': '+8618817310041'}, {'name': 'lei jiang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'jian chen, doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Jiang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lei Jiang', 'investigatorAffiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}}}}