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

February 3, 2020 updated by: Zhigang Li, Shanghai Chest Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xiaobin Zhang, Doctor
  • Phone Number: 86-18516302162
  • Email: zxb5212@163.com

Study Locations

  • China
      • Shanghai, China, SH 21
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiao Tong University
        • Contact:
      • Shanghai, China, SH 21
        • Recruiting
        • ChangHai Hospital, The Second Military Medical University
        • Contact:
      • Shanghai, China, SH 21
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:
      • Shanghai, China, SH 21
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, JS 25
        • Recruiting
        • General Hospital of Eastern Theater Command
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, JX 791
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • minimally invasive esophagectomy
Procedure: esophagectomy
Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
Other Names:
  • minimally invasive esophagectomy
ACTIVE_COMPARATOR: Thoracoscopic esophagectomy
Conventional thoracoscopic esophagectomy with gastric conduit formation.
Procedure: esophagectomy
Robot assisted esophagectomy with extended two field lymphadenectomy.
Other Names:
  • minimally invasive esophagectomy
Procedure: esophagectomy
Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
Other Names:
  • minimally invasive esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival Rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate
Time Frame: 3 years
3 years
R0 resection (%)
Time Frame: within 30 days after surgery
within 30 days after surgery
Disease Free Survival Rate
Time Frame: 3 years
3 years
Postoperative major complications
Time Frame: 30 days after surgery
30 days after surgery
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.
30-60 days after surgery
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.
during the operation, up to 5 hours
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
from the date of surgery to the hospital discharge, assessed up to 15 days
Number of lymph nodes dissected
Time Frame: within 30 days after surgery
within 30 days after surgery
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.
2 years
Estimated blood loss
Time Frame: during the operation, up to 5 hours
during the operation, up to 5 hours
Disease Free Survival Rate
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

Changhai Hospital
The First Affiliated Hospital of Nanchang University
Shanghai Zhongshan Hospital
Ruijin Hospital

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 29, 2017

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (ACTUAL)

March 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAE20170320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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