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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 3

Conditions: Esophageal Carcinoma; Esophageal Cancer

Treatments: Procedure: esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03094351

RAE20170320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

Robot assisted esophagectomy

Experimental group

Description:

Robot-assisted esophagectomy with gastric conduit formation.

Treatment:

Procedure: esophagectomy

Procedure: esophagectomy

Thoracoscopic esophagectomy

Active Comparator group

Description:

Conventional thoracoscopic esophagectomy with gastric conduit formation.

Treatment:

Procedure: esophagectomy

Procedure: esophagectomy