NCT03094351

Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Esophageal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	esophagectomy	Robot assisted esophagectomy with extended two field lymphadenectomy.
PROCEDURE	esophagectomy	Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.

Timeline

• Start date: 2017-07-29
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2017-03-29
• Last updated: 2020-02-05

Locations

6 sites across 1 country: China