Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy
RAE vs CTE
1 other identifier
interventional
360
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2017
Longer than P75 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedStudy Start
First participant enrolled
July 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 5, 2020
February 1, 2019
7.3 years
March 20, 2017
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival Rate
5 years
Secondary Outcomes (11)
R0 resection (%)
within 30 days after surgery
Overall Survival Rate
3 years
Disease Free Survival Rate
3 years
Postoperative major complications
30 days after surgery
In hospital mortality
30-60 days after surgery
- +6 more secondary outcomes
Study Arms (2)
Robot assisted esophagectomy
EXPERIMENTALRobot-assisted esophagectomy with gastric conduit formation.
Thoracoscopic esophagectomy
ACTIVE COMPARATORConventional thoracoscopic esophagectomy with gastric conduit formation.
Interventions
Robot assisted esophagectomy with extended two field lymphadenectomy.
Eligibility Criteria
You may qualify if:
- Histologically proven squamous cell carcinoma of the intrathoracic esophagus.
- 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
You may not qualify if:
- Carcinoma of the cervical esophagus
- Histologically proven adenocarcinoma or undifferentiated carcinoma.
- Prior thoracic surgery at the right hemithorax or thorax trauma.
- Infectious disease with systemic therapy indicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Chest Hospitallead
- Ruijin Hospitalcollaborator
- Changhai Hospitalcollaborator
- Shanghai Zhongshan Hospitalcollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
Study Sites (6)
General hospital of eastern theater command
Nanjing, Jiangsu, JS 25, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, JX 791, China
Changhai Hospital, The Second Military Medical University
Shanghai, SH 21, China
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, SH 21, China
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, SH 21, China
Zhongshan Hospital, Fudan University
Shanghai, SH 21, China
Related Publications (2)
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: 34171870DERIVEDYang 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.
PMID: 31226960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhigang Li, Master
Shanghai Chest Hospital of Shanghai Jiao Tong University
- STUDY DIRECTOR
Hecheng Li, Master
Ruijin Hospital
- STUDY DIRECTOR
Hezhong Chen, Master
Changhai Hospital, the Second Military Medical University
- STUDY DIRECTOR
Lijie Tan, Master
Fudan University
- STUDY DIRECTOR
Bentong Yu, Master
The First of Affiliated Hospital of Nanchang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief
Study Record Dates
First Submitted
March 20, 2017
First Posted
March 29, 2017
Study Start
July 29, 2017
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
February 5, 2020
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share