Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy
NCT ID: NCT03094351
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
360 participants
INTERVENTIONAL
2017-07-29
2024-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy
NCT06012214
RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).
NCT04306458
Robot-assisted IVOR-LEWIS Esophagectomy
NCT03140189
Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer
NCT02355249
Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy
NCT01544790
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study 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.
Intervention: 360 patients will be randomly allocated to either A) robot-assisted esophagectomy (n=180) or B) conventional thoracoscopic esophagectomy (n=180).
Patients will receive the following interventions:
Group A. robot assisted esophagectomy, with gastric conduit formation. Group B. conventional thoracoscopic esophagectomy, with gastric conduit formation.
Main study parameters/endpoints: Primary outcome is 5-year overall survival rate.
Secondary 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.
Follow-up: 60 months after discharge of the last randomized patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robot assisted esophagectomy
Robot-assisted esophagectomy with gastric conduit formation.
esophagectomy
Robot assisted esophagectomy with extended two field lymphadenectomy.
Thoracoscopic esophagectomy
Conventional thoracoscopic esophagectomy with gastric conduit formation.
esophagectomy
Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
esophagectomy
Robot assisted esophagectomy with extended two field lymphadenectomy.
esophagectomy
Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Surgical resectable (T1b-3, N0-2, M0)
* Age ≥ 18 and ≤ 75 years
* European Clinical Oncology Group performance status 0, 1 or 2
* Written informed consent
Exclusion Criteria
* Histologically proven adenocarcinoma or undifferentiated carcinoma.
* Prior thoracic surgery at the right hemithorax or thorax trauma.
* Infectious disease with systemic therapy indicated.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ruijin Hospital
OTHER
Changhai Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Shanghai Chest Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhigang Li
Chief
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhigang Li, Master
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital of Shanghai Jiao Tong University
Hecheng Li, Master
Role: STUDY_DIRECTOR
Ruijin Hospital
Hezhong Chen, Master
Role: STUDY_DIRECTOR
Changhai Hospital, the Second Military Medical University
Lijie Tan, Master
Role: STUDY_DIRECTOR
Fudan University
Bentong Yu, Master
Role: STUDY_DIRECTOR
The First of Affiliated Hospital of Nanchang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
General hospital of eastern theater command
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Changhai Hospital, The Second Military Medical University
Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, , China
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, , China
Zhongshan Hospital, Fudan University
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RAE20170320
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.