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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Changhai Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| The First Affiliated Hospital of Nanchang University |
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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.
Objective: This study aims to compare the oncological outcomes between robot-assisted esophagectomy and minimally invasive conventional thoracoscopic esophagectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted esophagectomy | Experimental | Robot-assisted esophagectomy with gastric conduit formation. |
|
| Thoracoscopic esophagectomy | Active Comparator | Conventional thoracoscopic esophagectomy with gastric conduit formation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esophagectomy | Procedure | Robot assisted esophagectomy with extended two field lymphadenectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection (%) | within 30 days after surgery | |
| Overall Survival Rate | 3 years | |
| Disease Free Survival Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhigang Li, Master | Contact | 86-18930619260 | zhigang.li@shchest.org | |
| Xiaobin Zhang, Doctor | Contact | 86-18516302162 | zxb5212@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhigang Li, Master | Shanghai Chest Hospital of Shanghai Jiao Tong University | Principal Investigator |
| Hecheng Li, Master | Ruijin Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General hospital of eastern theater command | Recruiting | Nanjing | Jiangsu | JS 25 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41932350 | Derived | Yang Y, Liu Z, Li C, Li B, Yu B, Yi J, Zhang X, Chen H, Li H, Tan L, Hua R, Guo X, Yang X, Ma W, Sun Y, Li Z; RAMIE study group. Robot-assisted versus conventional minimally invasive oesophagectomy for oesophageal squamous cell carcinoma (RAMIE): a multicentre, open-label, randomised, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026 Jun;11(6):452-462. doi: 10.1016/S2468-1253(25)00402-9. Epub 2026 Mar 31. | |
| 34171870 |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Not provided
| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
Parallel Assignment
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Open Label
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| esophagectomy | Procedure | Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy. |
|
|
| 3 years |
| Postoperative major complications | 30 days after surgery |
| In hospital mortality | For all patients, the cause of death will be noted. If applicable, the results of the autopsy report will be noted. | 30-60 days after surgery |
| Operative duration | 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. | during the operation, up to 5 hours |
| Postoperative recovery | Postoperative hospital stay, intensive care unit (ICU) stay | from the date of surgery to the hospital discharge, assessed up to 15 days |
| Number of lymph nodes dissected | within 30 days after surgery |
| Quality of life | 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. | 2 years |
| Estimated blood loss | during the operation, up to 5 hours |
| Disease Free Survival Rate | 5 years |
| 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 | Study Director |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | JX 791 | China |
|
| Changhai Hospital, The Second Military Medical University | Recruiting | Shanghai | SH 21 | China |
|
| Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine | Recruiting | Shanghai | SH 21 | China |
|
| Shanghai Chest Hospital, Shanghai Jiao Tong University | Recruiting | Shanghai | SH 21 | China |
|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | SH 21 | China |
|
| Derived |
| 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. |
| 31226960 | Derived | 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. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |