Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 8:52 AM
Study NCT ID:
NCT02804893
Status:
UNKNOWN
Last Update Posted:
2018-12-20
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020775', 'term': 'Thoracic Surgery, Video-Assisted'}], 'ancestors': [{'id': 'D013906', 'term': 'Thoracoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D020535', 'term': 'Video-Assisted Surgery'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2023-03-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative complications: conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other)', 'timeFrame': 'date of Surgery'}, {'measure': 'Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days', 'timeFrame': 'within 90 days'}], 'secondaryOutcomes': [{'measure': 'Duration of surgery', 'timeFrame': 'date of Surgery'}, {'measure': 'Number of resected lymph nodes and upstaging', 'timeFrame': 'date of Surgery'}, {'measure': 'Proportion of patients who undergo complete resection during the procedure', 'timeFrame': 'date of Surgery'}, {'measure': 'Postoperative hospital stay', 'timeFrame': '2 weeks'}, {'measure': 'Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge', 'timeFrame': '2 weeks, 6 months and 12 months'}, {'measure': 'Quality of life by EORTC QOL-C30', 'timeFrame': '2 weeks, 6 months and 12 months'}, {'measure': 'Duration of analgesic use after discharge and time to return to normal daily activity', 'timeFrame': 'within 90 days'}, {'measure': 'Postoperative respiratory function: FEV 1, PEF and CV', 'timeFrame': '6 month postoperatively'}, {'measure': 'Rate of local and distant recurrence and disease free survival', 'timeFrame': '24 months'}, {'measure': "Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations", 'timeFrame': 'before surgery, 2 hours after surgery and at 3rd and 14th postoperative day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer, video-assisted thoracoscopic surgery, robotic-assisted thoracoscopic surgery'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '10421140', 'type': 'RESULT', 'citation': 'Demmy TL, Curtis JJ. Minimally invasive lobectomy directed toward frail and high-risk patients: a case-control study. Ann Thorac Surg. 1999 Jul;68(1):194-200. doi: 10.1016/s0003-4975(99)00467-1.'}, {'pmid': '12632277', 'type': 'RESULT', 'citation': 'Hoksch B, Ablassmaier B, Walter M, Muller JM. [Complication rate after thoracoscopic and conventional lobectomy]. Zentralbl Chir. 2003 Feb;128(2):106-10. doi: 10.1055/s-2003-37763. German.'}, {'pmid': '11016337', 'type': 'RESULT', 'citation': 'Nakata M, Saeki H, Yokoyama N, Kurita A, Takiyama W, Takashima S. Pulmonary function after lobectomy: video-assisted thoracic surgery versus thoracotomy. Ann Thorac Surg. 2000 Sep;70(3):938-41. doi: 10.1016/s0003-4975(00)01513-7.'}, {'pmid': '12560900', 'type': 'RESULT', 'citation': 'Nomori H, Ohtsuka T, Horio H, Naruke T, Suemasu K. Difference in the impairment of vital capacity and 6-minute walking after a lobectomy performed by thoracoscopic surgery, an anterior limited thoracotomy, an anteroaxillary thoracotomy, and a posterolateral thoracotomy. Surg Today. 2003;33(1):7-12. doi: 10.1007/s005950300001.'}, {'pmid': '10921716', 'type': 'RESULT', 'citation': 'Yim AP, Wan S, Lee TW, Arifi AA. VATS lobectomy reduces cytokine responses compared with conventional surgery. Ann Thorac Surg. 2000 Jul;70(1):243-7. doi: 10.1016/s0003-4975(00)01258-3.'}, {'pmid': '12614812', 'type': 'RESULT', 'citation': 'Li WW, Lee RL, Lee TW, Ng CS, Sihoe AD, Wan IY, Arifi AA, Yim AP. The impact of thoracic surgical access on early shoulder function: video-assisted thoracic surgery versus posterolateral thoracotomy. Eur J Cardiothorac Surg. 2003 Mar;23(3):390-6. doi: 10.1016/s1010-7940(02)00795-9.'}, {'pmid': '9930466', 'type': 'RESULT', 'citation': 'McKenna RJ Jr, Wolf RK, Brenner M, Fischel RJ, Wurnig P. Is lobectomy by video-assisted thoracic surgery an adequate cancer operation? Ann Thorac Surg. 1998 Dec;66(6):1903-8. doi: 10.1016/s0003-4975(98)01166-7.'}, {'pmid': '12895606', 'type': 'RESULT', 'citation': 'Leschber G, Holinka G, Linder A. Video-assisted mediastinoscopic lymphadenectomy (VAMLA)--a method for systematic mediastinal lymphnode dissection. Eur J Cardiothorac Surg. 2003 Aug;24(2):192-5. doi: 10.1016/s1010-7940(03)00253-7.'}, {'pmid': '9800798', 'type': 'RESULT', 'citation': 'Yim AP, Landreneau RJ, Izzat MB, Fung AL, Wan S. Is video-assisted thoracoscopic lobectomy a unified approach? Ann Thorac Surg. 1998 Oct;66(4):1155-8. doi: 10.1016/s0003-4975(98)00622-5.'}, {'pmid': '24504007', 'type': 'RESULT', 'citation': 'Cao C, Tian DH, Wolak K, Oparka J, He J, Dunning J, Walker WS, Yan TD. Cross-sectional survey on lobectomy approach (X-SOLA). Chest. 2014 Aug;146(2):292-298. doi: 10.1378/chest.13-1075.'}, {'pmid': '12238851', 'type': 'RESULT', 'citation': "Daniels LJ, Balderson SS, Onaitis MW, D'Amico TA. Thoracoscopic lobectomy: a safe and effective strategy for patients with stage I lung cancer. Ann Thorac Surg. 2002 Sep;74(3):860-4. doi: 10.1016/s0003-4975(02)03764-5."}, {'pmid': '12062276', 'type': 'RESULT', 'citation': 'Melfi FM, Menconi GF, Mariani AM, Angeletti CA. Early experience with robotic technology for thoracoscopic surgery. Eur J Cardiothorac Surg. 2002 May;21(5):864-8. doi: 10.1016/s1010-7940(02)00102-1.'}, {'pmid': '16399294', 'type': 'RESULT', 'citation': 'Park BJ, Flores RM, Rusch VW. Robotic assistance for video-assisted thoracic surgical lobectomy: technique and initial results. J Thorac Cardiovasc Surg. 2006 Jan;131(1):54-9. doi: 10.1016/j.jtcvs.2005.07.031.'}, {'pmid': '19632377', 'type': 'RESULT', 'citation': 'Gharagozloo F, Margolis M, Tempesta B, Strother E, Najam F. Robot-assisted lobectomy for early-stage lung cancer: report of 100 consecutive cases. Ann Thorac Surg. 2009 Aug;88(2):380-4. doi: 10.1016/j.athoracsur.2009.04.039.'}, {'pmid': '20038475', 'type': 'RESULT', 'citation': 'Veronesi G, Galetta D, Maisonneuve P, Melfi F, Schmid RA, Borri A, Vannucci F, Spaggiari L. Four-arm robotic lobectomy for the treatment of early-stage lung cancer. J Thorac Cardiovasc Surg. 2010 Jul;140(1):19-25. doi: 10.1016/j.jtcvs.2009.10.025. Epub 2009 Dec 28.'}, {'pmid': '22440364', 'type': 'RESULT', 'citation': 'Louie BE, Farivar AS, Aye RW, Vallieres E. Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg. 2012 May;93(5):1598-604; discussion 1604-5. doi: 10.1016/j.athoracsur.2012.01.067. Epub 2012 Mar 20.'}, {'pmid': '24583699', 'type': 'RESULT', 'citation': 'Nakamura H. Systematic review of published studies on safety and efficacy of thoracoscopic and robot-assisted lobectomy for lung cancer. Ann Thorac Cardiovasc Surg. 2014;20(2):93-8. doi: 10.5761/atcs.ra.13-00314. Epub 2014 Feb 28.'}, {'pmid': '34568057', 'type': 'DERIVED', 'citation': 'Veronesi G, Abbas AE, Muriana P, Lembo R, Bottoni E, Perroni G, Testori A, Dieci E, Bakhos CT, Car S, Luzzi L, Alloisio M, Novellis P. Perioperative Outcome of Robotic Approach Versus Manual Videothoracoscopic Major Resection in Patients Affected by Early Lung Cancer: Results of a Randomized Multicentric Study (ROMAN Study). Front Oncol. 2021 Sep 9;11:726408. doi: 10.3389/fonc.2021.726408. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18 years old\n* Known or suspected lung cancers\n* Patients in clinical stage T1-T2, N0-N1 candidate to surgery lobectomy or anatomical segmentectomy\n* ASA-1-2-3\n\nExclusion Criteria:\n\n* Clinical stage \\>II\n* Severe heart disease\n* Alcohol abuse\n* Renal impairment (creatinine \\>2.5)\n* Presence of serious comorbidities'}, 'identificationModule': {'nctId': 'NCT02804893', 'acronym': 'ROMAN', 'briefTitle': 'Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Prospective, Randomized, Multicentric Study On Videothoracoscopic (Vats) Vs Robotic Approach For Lobectomy Or Anatomical Segmentectomy In Patients Affected By Early Lung Cancer (ROMAN)', 'orgStudyIdInfo': {'id': '1566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VATS GROUP', 'description': 'VATS lobectomy or segmentectomy', 'interventionNames': ['Procedure: VATS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RATS GROUP', 'description': 'Robotic lobectomy or segmentectomy', 'interventionNames': ['Procedure: RATS']}], 'interventions': [{'name': 'VATS', 'type': 'PROCEDURE', 'otherNames': ['Minimally invasive video-assisted surgery'], 'description': 'Thorax thoracoscopic surgery (lobectomy)', 'armGroupLabels': ['VATS GROUP']}, {'name': 'RATS', 'type': 'PROCEDURE', 'otherNames': ['Minimally invasive robot-assisted surgery'], 'description': 'Thorax robotic surgery (lobectomy)', 'armGroupLabels': ['RATS GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulia Veronesi, MD', 'role': 'CONTACT', 'email': 'giulia.veronesi@cancercenter.humanitas.it', 'phone': '+39 (0)2 82247396'}, {'name': 'Elisa Dieci, PhD', 'role': 'CONTACT', 'email': 'elisa.dieci@cancercenter.humanitas.it', 'phone': '+39(0)282244594'}, {'name': 'Giulia Veronesi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marco Alloisio, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alberto Testori, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Thoracic surgery Division, Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Umberto Veronesi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}