Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy

Phase 3

Recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Thoracoscopic esophagectomy	esophagectomy	Conventional thoracoscopic esophagectomy with gastric conduit formation.
Robot assisted esophagectomy	esophagectomy	Robot-assisted esophagectomy with gastric conduit formation.

Primary Outcome Measures

Name	Time	Method
Overall Survival Rate	5 years

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival Rate	5 years
In hospital mortality	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.
R0 resection (%)	within 30 days after surgery
Overall Survival Rate	3 years
Operative duration	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	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	within 30 days after surgery
Estimated blood loss	during the operation, up to 5 hours
Quality of life	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.
Postoperative major complications	30 days after surgery

Locations (6): General hospital of eastern theater command
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Nanjing, Jiangsu, China
Changhai Hospital, The Second Military Medical University
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Shanghai, China
The First Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, China
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
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Shanghai, China
Zhongshan Hospital, Fudan University
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Shanghai, China
Shanghai Chest Hospital, Shanghai Jiao Tong University
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Shanghai, China