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

• ClinicalTrials.gov Identifier: NCT03094351
• Recruitment Status: Recruiting
• First Posted: March 29, 2017
• Last Update Posted: February 5, 2020
• Sponsor: Shanghai Chest Hospital
• 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

Tracking Information

• First Submitted Date: March 20, 2017
• First Posted Date: March 29, 2017
• Last Update Posted Date: February 5, 2020
• Actual Study Start Date: July 29, 2017
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 14, 2017): Overall Survival Rate [ Time Frame: 5 years ]

Original Primary Outcome Measures (submitted: March 23, 2017)

• Overall Survival Rate [ Time Frame: 5 years ]
• Disease Free Survival Rate [ Time Frame: 5 years ]

Current Secondary Outcome Measures (submitted: May 14, 2017)

• R0 resection (%) [ Time Frame: within 30 days after surgery ]
• Overall Survival Rate [ Time Frame: 3 years ]
• Disease Free Survival Rate [ Time Frame: 3 years ]
• Postoperative major complications [ Time Frame: 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.
• 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.
• 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
• Number of lymph nodes dissected [ Time Frame: 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.
• Estimated blood loss [ Time Frame: during the operation, up to 5 hours ]
• Disease Free Survival Rate [ Time Frame: 5 years ]

Original Secondary Outcome Measures (submitted: March 23, 2017)

• R0 resection (%) [ Time Frame: within 30 days after surgery ]
• Overall Survival Rate [ Time Frame: 3 years ]
• Disease Free Survival Rate [ Time Frame: 3 years ]
• Postoperative major complications [ Time Frame: 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.
• 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.
• 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
• Number of lymph nodes dissected [ Time Frame: 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.
• Estimated blood loss [ Time Frame: during the operation, up to 5 hours ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy
• 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)
• 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.

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
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel Assignment

Masking: None (Open Label)
Masking Description:

Open Label

Primary Purpose: Treatment

Condition

• Esophageal Cancer
• Esophageal Carcinoma

Intervention

• Procedure: esophagectomy
  Robot assisted esophagectomy with extended two field lymphadenectomy.
  Other Name: minimally invasive esophagectomy
• Procedure: esophagectomy
  Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
  Other Name: minimally invasive esophagectomy

Study Arms

• Experimental: Robot assisted esophagectomy
  Robot-assisted esophagectomy with gastric conduit formation.
  Intervention: Procedure: esophagectomy
• Active Comparator: Thoracoscopic esophagectomy
  Conventional thoracoscopic esophagectomy with gastric conduit formation.
  Intervention: Procedure: esophagectomy

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 10, 2018): 360
• Original Estimated Enrollment (submitted: March 23, 2017): 300
• Estimated Study Completion Date: December 1, 2024
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Zhigang Li, Master; 86-18930619260; zhigang.li@shchest.org

Contact: Xiaobin Zhang, Doctor; 86-18516302162; zxb5212@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03094351
• Other Study ID Numbers: RAE20170320
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Zhigang Li, Shanghai Chest Hospital
• Original Responsible Party: Zhiang Li, Shanghai Chest Hospital, Chief
• Current Study Sponsor: Shanghai Chest Hospital
• Original Study Sponsor: Zhiang Li

Collaborators

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

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

• PRS Account: Shanghai Chest Hospital
• Verification Date: February 2019