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Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy (RAE vs CTE)

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ClinicalTrials.gov Identifier: NCT03094351
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Ruijin Hospital
Changhai Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Nanchang University
Information provided by (Responsible Party):
Zhigang Li, Shanghai Chest Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Esophageal Carcinoma Procedure: esophagectomy Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)
Actual Study Start Date : July 29, 2017
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Robot assisted esophagectomy
Robot-assisted esophagectomy with gastric conduit formation.
 Procedure: esophagectomy
Robot assisted esophagectomy with extended two field lymphadenectomy.
Other Name: minimally invasive esophagectomy
Active Comparator: Thoracoscopic esophagectomy
Conventional thoracoscopic esophagectomy with gastric conduit formation.
 Procedure: esophagectomy
Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
Other Name: minimally invasive esophagectomy


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. R0 resection (%) [ Time Frame: within 30 days after surgery ]
  2. Overall Survival Rate [ Time Frame: 3 years ]
  3. Disease Free Survival Rate [ Time Frame: 3 years ]
  4. Postoperative major complications [ Time Frame: 30 days after surgery ]
  5. In hospital mortality [ Time Frame: 30-60 days after surgery ]
    For all patients, the cause of death will be noted. If applicable, the results of the autopsy report will be noted.

  6. Operative duration [ Time Frame: during the operation, up to 5 hours ]
    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.

  7. Postoperative recovery [ Time Frame: from the date of surgery to the hospital discharge, assessed up to 15 days ]
    Postoperative hospital stay, intensive care unit (ICU) stay

  8. Number of lymph nodes dissected [ Time Frame: within 30 days after surgery ]
  9. Quality of life [ Time Frame: 2 years ]
    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.

  10. Estimated blood loss [ Time Frame: during the operation, up to 5 hours ]
  11. Disease Free Survival Rate [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094351


Contacts
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Contact: Zhigang Li, Master 86-18930619260 zhigang.li@shchest.org
Contact: Xiaobin Zhang, Doctor 86-18516302162 zxb5212@163.com

Locations
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China, Jiangsu
General hospital of eastern theater command Recruiting
Nanjing, Jiangsu, China, JS 25
Contact: Jun Yi, Doctor    8613675101301    njyijun@163.com   
China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, JX 791
Contact: Bentong Yu, Doctor    86-13870614026    yubentong@126.com   
China
Changhai Hospital, The Second Military Medical University Recruiting
Shanghai, China, SH 21
Contact: Hezhong Chen, Doctor    86-13301783183    drchenhz@citiz.net   
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, China, SH 21
Contact: Hecheng Li, Doctor    86-13917113402    lihecheng2000@hotmail.com   
Shanghai Chest Hospital, Shanghai Jiao Tong University Recruiting
Shanghai, China, SH 21
Contact: Zhigang Li, Doctor    86-18930619260    zhigang.li@shchest.org   
Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, SH 21
Contact: Lijie Tan, Doctor    86-13681972151    tan.lijie@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Chest Hospital
Ruijin Hospital
Changhai Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Nanchang University
Investigators
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Principal Investigator: Zhigang Li, Master Shanghai Chest Hospital, 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhigang Li, Chief, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03094351    
Other Study ID Numbers: RAE20170320
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhigang Li, Shanghai Chest Hospital:
robot assisted esophagectomy
minimally invasive esophagectomy
esophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases