Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-01 @ 1:59 AM
Study NCT ID:
NCT03134534
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2017-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot-assisted vs VATS Lobectomy for NSCLC
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-28', 'studyFirstSubmitDate': '2017-04-15', 'studyFirstSubmitQcDate': '2017-04-28', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'total hospitalization expenditures', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'cost in hospital'}], 'primaryOutcomes': [{'measure': '3-year overall survival (OS)', 'timeFrame': '3 year after surgery', 'description': 'OS at 3 year after surgery'}, {'measure': 'Lymph node counts', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station'}], 'secondaryOutcomes': [{'measure': '3-year disease-free survival (DFS)', 'timeFrame': '3 year after surgery', 'description': 'DFS at 3 year after surgery'}, {'measure': '1-year overall survival (OS)', 'timeFrame': '1 year after surgery', 'description': 'OS at 1 year after surgery'}, {'measure': '1-year disease-free survival (DFS)', 'timeFrame': '1 year after surgery', 'description': 'DFS at 1 year after surgery'}, {'measure': 'R0 rate', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'R0 radical rate'}, {'measure': 'margin state', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'positive margin rate'}, {'measure': 'operative time', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'the time of operation'}, {'measure': 'blood loss', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'blood loss in the operation'}, {'measure': 'conversion rate', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'the rate of conversion to open surgery in the operation'}, {'measure': 'operative accident event', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'the accident event happened in operative'}, {'measure': '30-day mortality', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': '30-day mortality after surgery'}, {'measure': 'length of stay (LOS)', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'length of stay in hospitalization'}, {'measure': 'postoperative complications', 'timeFrame': 'postoperative in-hospital stay up to 30 days', 'description': 'mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula'}, {'measure': 'quality of life (QOL) at 3 month', 'timeFrame': 'at 3 month after surgery', 'description': 'QOL, WHOQOL-BREF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lobectomy', 'robot-assisted thoracoscopic surgery', 'lung cancer'], 'conditions': ['Pulmonary Neoplasm']}, 'referencesModule': {'references': [{'pmid': '40658465', 'type': 'DERIVED', 'citation': 'Li C, Chen X, Wang X, Guo W, Zhang Y, Chen F, Li H. Single-Port Robotic-Assisted Approach in Thoracic Surgery: A Prospective Real-World Study. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf161. doi: 10.1093/icvts/ivaf161.'}, {'pmid': '39105193', 'type': 'DERIVED', 'citation': 'Niu Z, Cao Y, Du M, Sun S, Yan Y, Zheng Y, Han Y, Zhang X, Zhang Z, Yuan Y, Li J, Zhang Y, Li C, Han D, Du H, Guo W, Chen K, Xiang J, Zhu L, Che J, Hang J, Ren J, Lerut T, Abbas AE, Lin J, Jin R, Li H. Robotic-assisted versus video-assisted lobectomy for resectable non-small-cell lung cancer: the RVlob randomized controlled trial. EClinicalMedicine. 2024 Jul 12;74:102707. doi: 10.1016/j.eclinm.2024.102707. eCollection 2024 Aug.'}, {'pmid': '36621757', 'type': 'DERIVED', 'citation': 'Jin R, Zhang Z, Zheng Y, Niu Z, Sun S, Cao Y, Zhang Y, Abbas AE, Lerut T, Lin J, Li H. Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial. Chest. 2023 Jun;163(6):1576-1588. doi: 10.1016/j.chest.2022.12.037. Epub 2023 Jan 5.'}, {'pmid': '33938492', 'type': 'DERIVED', 'citation': 'Jin R, Zheng Y, Yuan Y, Han D, Cao Y, Zhang Y, Li C, Xiang J, Zhang Z, Niu Z, Lerut T, Lin J, Abbas AE, Pardolesi A, Suda T, Amore D, Schraag S, Aigner C, Li J, Che J, Hang J, Ren J, Zhu L, Li H. Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial). Ann Surg. 2022 Feb 1;275(2):295-302. doi: 10.1097/SLA.0000000000004922.'}]}, 'descriptionModule': {'briefSummary': 'Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.', 'detailedDescription': 'Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. surgical indication for lobectomy;\n2. minimal invasive surgery;\n3. ASA (American Society of Anesthesiologists) stage: I-III;\n4. sign the informed consent. -\n\nExclusion Criteria:\n\n1. benign tumor or nodule;\n2. present of other malignancy;\n3. preoperative chemotherapy, radiotherapy, targeted therapy. -'}, 'identificationModule': {'nctId': 'NCT03134534', 'acronym': 'RVlob', 'briefTitle': 'Robot-assisted vs VATS Lobectomy for NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Study of Robotic-assisted Thoracoscopic Lobectomy Versus Video-assisted Thoracoscopic Lobectomy for Non-small Cell Lung Cancer (RVlob)', 'orgStudyIdInfo': {'id': 'RTS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'VATS group', 'description': 'Surgical procedure: VATS lobectomy', 'interventionNames': ['Procedure: VATS lobectomy']}, {'type': 'OTHER', 'label': 'RATS group', 'description': 'Surgical procedure: RATS lobectomy', 'interventionNames': ['Procedure: RATS lobectomy']}], 'interventions': [{'name': 'VATS lobectomy', 'type': 'PROCEDURE', 'description': 'a minimal invasive surgical types for NSCLC: VATS lobectomy', 'armGroupLabels': ['VATS group']}, {'name': 'RATS lobectomy', 'type': 'PROCEDURE', 'description': 'a minimal invasive surgical types for NSCLC: RATS lobectomy', 'armGroupLabels': ['RATS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '021', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai JiaoTong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'He-Cheng Li, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hecheng Li M.D., Ph.D', 'investigatorAffiliation': 'Ruijin Hospital'}}}}