Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy

Esophageal Cancer Clinical Trial

— RAE vs CTE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03094351
• Other study ID #: RAE20170320
• Status: Recruiting
• Phase: Phase 3
• Start date: July 29, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2019
• Source: Shanghai Chest Hospital
• Contact: Zhigang Li, Master
• Phone: 86-18930619260
• Email: zhigang.li[@]shchest.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Procedure:
• esophagectomy
Robot assisted esophagectomy with extended two field lymphadenectomy.
• esophagectomy
Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	General hospital of eastern theater command	Nanjing	Jiangsu
China	Changhai Hospital, The Second Military Medical University	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai
China	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Changhai Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Rate		5 years
Secondary	R0 resection (%)		within 30 days after surgery
Secondary	Overall Survival Rate		3 years
Secondary	Disease Free Survival Rate		3 years
Secondary	Postoperative major complications		30 days after surgery
Secondary	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
Secondary	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
Secondary	Postoperative recovery	Postoperative hospital stay, intensive care unit (ICU) stay	from the date of surgery to the hospital discharge, assessed up to 15 days
Secondary	Number of lymph nodes dissected		within 30 days after surgery
Secondary	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
Secondary	Estimated blood loss		during the operation, up to 5 hours
Secondary	Disease Free Survival Rate		5 years