Clinical trial NCT03094351: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Cancer
Esophageal Carcinoma
Keywords: robot assisted esophagectomy
minimally invasive esophagectomy
esophageal cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Changhai Hospital
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital of Nanchang University
First posted: 2017-03-29
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Survival Rate
timeFrame: 5 years
Secondary outcomes:
measure: R0 resection (%)
timeFrame: within 30 days after surgery
measure: Overall Survival Rate
timeFrame: 3 years
measure: Disease Free Survival Rate
timeFrame: 3 years
measure: Postoperative major complications
timeFrame: 30 days after surgery
measure: In hospital mortality
timeFrame: 30-60 days after surgery
measure: Operative duration
timeFrame: during the operation, up to 5 hours
measure: Postoperative recovery
timeFrame: from the date of surgery to the hospital discharge, assessed up to 15 days
measure: Number of lymph nodes dissected
timeFrame: within 30 days after surgery
measure: Quality of life
timeFrame: 2 years
measure: Estimated blood loss
timeFrame: during the operation, up to 5 hours
measure: Disease Free Survival Rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: General hospital of eastern theater command
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Changhai Hospital, The Second Military Medical University
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Shanghai Chest Hospital of Shanghai Jiao Tong University
name: Zhigang Li, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Hecheng Li, Master
role: STUDY_DIRECTOR
affiliation: Changhai Hospital, the Second Military Medical University
name: Hezhong Chen, Master
role: STUDY_DIRECTOR
affiliation: Fudan University
name: Lijie Tan, Master
role: STUDY_DIRECTOR
affiliation: The First of Affiliated Hospital of Nanchang University
name: Bentong Yu, Master
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.