Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-22 @ 8:43 AM
Study NCT ID:
NCT03094351
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival Rate', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'R0 resection (%)', 'timeFrame': 'within 30 days after surgery'}, {'measure': 'Overall Survival Rate', 'timeFrame': '3 years'}, {'measure': 'Disease Free Survival Rate', 'timeFrame': '3 years'}, {'measure': 'Postoperative major complications', 'timeFrame': '30 days after surgery'}, {'measure': 'In hospital mortality', 'timeFrame': '30-60 days after surgery', 'description': 'For all patients, the cause of death will be noted. If applicable, the results of the autopsy report will be noted.'}, {'measure': 'Operative duration', 'timeFrame': 'during the operation, up to 5 hours', 'description': 'The operation time is defined as time from incision until closure (minutes) for both the thoracic phase and the abdominal phase of the procedure. For the robotic procedure, the set-up time will be recorded separately.'}, {'measure': 'Postoperative recovery', 'timeFrame': 'from the date of surgery to the hospital discharge, assessed up to 15 days', 'description': 'Postoperative hospital stay, intensive care unit (ICU) stay'}, {'measure': 'Number of lymph nodes dissected', 'timeFrame': 'within 30 days after surgery'}, {'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'The quality of life assessment was based on a previously validated questionnaire, QLQ-C30 (version 3.0; quality-of-life questionnaire), combined with an esophageal cancer-specific module, QLQ-OES18.'}, {'measure': 'Estimated blood loss', 'timeFrame': 'during the operation, up to 5 hours'}, {'measure': 'Disease Free Survival Rate', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['robot assisted esophagectomy', 'minimally invasive esophagectomy', 'esophageal cancer'], 'conditions': ['Esophageal Cancer', 'Esophageal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '34171870', 'type': 'DERIVED', 'citation': 'Yang Y, Li B, Yi J, Hua R, Chen H, Tan L, Li H, He Y, Guo X, Sun Y, Yu B, Li Z. Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Resectable Esophageal Squamous Cell Carcinoma: Early Results of a Multicenter Randomized Controlled Trial: the RAMIE Trial. Ann Surg. 2022 Apr 1;275(4):646-653. doi: 10.1097/SLA.0000000000005023.'}, {'pmid': '31226960', 'type': 'DERIVED', 'citation': 'Yang Y, Zhang X, Li B, Li Z, Sun Y, Mao T, Hua R, Yang Y, Guo X, He Y, Li H, Chen H, Tan L. Robot-assisted esophagectomy (RAE) versus conventional minimally invasive esophagectomy (MIE) for resectable esophageal squamous cell carcinoma: protocol for a multicenter prospective randomized controlled trial (RAMIE trial, robot-assisted minimally invasive Esophagectomy). BMC Cancer. 2019 Jun 21;19(1):608. doi: 10.1186/s12885-019-5799-6.'}]}, 'descriptionModule': {'briefSummary': 'This is the first randomized controlled study to compare the robot-assisted esophagectomy (RAE) to minimally invasive conventional thoracoscopic esophagectomy (CTE). The aim of this trial is to evaluate the safety, risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes and long-term oncological outcomes between the two surgical treatments.', 'detailedDescription': 'Objective: This study aims to compare the oncological outcomes between robot-assisted esophagectomy and minimally invasive conventional thoracoscopic esophagectomy.\n\nStudy design: Randomized controlled parallel-group superiority trial Study population: Patients (age \\>= 18 and \\<= 75 years) with histologically proven surgically resectable (cT1b-3, N0-2, M0) squamous cell carcinoma of the intrathoracic esophagus with European Clinical Oncology Group performance status 0, 1 or 2.\n\nIntervention: 360 patients will be randomly allocated to either A) robot-assisted esophagectomy (n=180) or B) conventional thoracoscopic esophagectomy (n=180).\n\nPatients will receive the following interventions:\n\nGroup A. robot assisted esophagectomy, with gastric conduit formation. Group B. conventional thoracoscopic esophagectomy, with gastric conduit formation.\n\nMain study parameters/endpoints: Primary outcome is 5-year overall survival rate.\n\nSecondary outcomes are 5-year disease free survival, 3-year overall survival rate, 3-year disease free survival, (in hospital) mortality within 30 and 60 days, R0 resections, operation related events, postoperative recovery, lymph nodes status, quality of life.\n\nFollow-up: 60 months after discharge of the last randomized patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven squamous cell carcinoma of the intrathoracic esophagus.\n* Surgical resectable (T1b-3, N0-2, M0)\n* Age ≥ 18 and ≤ 75 years\n* European Clinical Oncology Group performance status 0, 1 or 2\n* Written informed consent\n\nExclusion Criteria:\n\n* Carcinoma of the cervical esophagus\n* Histologically proven adenocarcinoma or undifferentiated carcinoma.\n* Prior thoracic surgery at the right hemithorax or thorax trauma.\n* Infectious disease with systemic therapy indicated.'}, 'identificationModule': {'nctId': 'NCT03094351', 'acronym': 'RAE vs CTE', 'briefTitle': 'Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)', 'orgStudyIdInfo': {'id': 'RAE20170320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot assisted esophagectomy', 'description': 'Robot-assisted esophagectomy with gastric conduit formation.', 'interventionNames': ['Procedure: esophagectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracoscopic esophagectomy', 'description': 'Conventional thoracoscopic esophagectomy with gastric conduit formation.', 'interventionNames': ['Procedure: esophagectomy']}], 'interventions': [{'name': 'esophagectomy', 'type': 'PROCEDURE', 'otherNames': ['minimally invasive esophagectomy'], 'description': 'Robot assisted esophagectomy with extended two field lymphadenectomy.', 'armGroupLabels': ['Robot assisted esophagectomy']}, {'name': 'esophagectomy', 'type': 'PROCEDURE', 'otherNames': ['minimally invasive esophagectomy'], 'description': 'Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.', 'armGroupLabels': ['Thoracoscopic esophagectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'JS 25', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Yi, Doctor', 'role': 'CONTACT', 'email': 'njyijun@163.com', 'phone': '8613675101301'}], 'facility': 'General hospital of eastern theater command', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': 'JX 791', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bentong Yu, Doctor', 'role': 'CONTACT', 'email': 'yubentong@126.com', 'phone': '86-13870614026'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': 'SH 21', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hezhong Chen, Doctor', 'role': 'CONTACT', 'email': 'drchenhz@citiz.net', 'phone': '86-13301783183'}], 'facility': 'Changhai Hospital, The Second Military Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': 'SH 21', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hecheng Li, Doctor', 'role': 'CONTACT', 'email': 'lihecheng2000@hotmail.com', 'phone': '86-13917113402'}], 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': 'SH 21', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhigang Li, Doctor', 'role': 'CONTACT', 'email': 'zhigang.li@shchest.org', 'phone': '86-18930619260'}], 'facility': 'Shanghai Chest Hospital, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': 'SH 21', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lijie Tan, Doctor', 'role': 'CONTACT', 'email': 'tan.lijie@zs-hospital.sh.cn', 'phone': '86-13681972151'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhigang Li, Master', 'role': 'CONTACT', 'email': 'zhigang.li@shchest.org', 'phone': '86-18930619260'}, {'name': 'Xiaobin Zhang, Doctor', 'role': 'CONTACT', 'email': 'zxb5212@163.com', 'phone': '86-18516302162'}], 'overallOfficials': [{'name': 'Zhigang Li, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital of Shanghai Jiao Tong University'}, {'name': 'Hecheng Li, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Hezhong Chen, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Changhai Hospital, the Second Military Medical University'}, {'name': 'Lijie Tan, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fudan University'}, {'name': 'Bentong Yu, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First of Affiliated Hospital of Nanchang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief', 'investigatorFullName': 'Zhigang Li', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}