Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)

Conditions
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Esophageal Cancer, Esophageal Carcinoma

Intervention / Treatment
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* Procedure: esophagectomy
* Procedure: esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot assisted esophagectomy<br>Robot-assisted esophagectomy with gastric conduit formation. | Procedure: esophagectomy<br>* Robot assisted esophagectomy with extended two field lymphadenectomy.<br>* Other names: minimally invasive esophagectomy;|
| Active Comparator: Thoracoscopic esophagectomy<br>Conventional thoracoscopic esophagectomy with gastric conduit formation. | Procedure: esophagectomy<br>* Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.<br>* Other names: minimally invasive esophagectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot assisted esophagectomy, minimally invasive esophagectomy, esophageal cancer