A Phase 3 interventional study of Modular Robot-Assisted Esophagectomy and Conventional Minimally Invasive Esophagectomy in Esophageal Cancer, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Ruijin Hospital · Phase 3, Interventional, and Treatment
This study evaluates the safety, efficacy, and health economic outcomes of modular robotic-assisted minimally invasive esophagectomy (RAMIE) compared with conventional thoracoscopic minimally invasive esophagectomy (MIE) in patients with resectable esophageal cancer.
Participants are randomly assigned in a 1:1 ratio to undergo either modular robotic-assisted esophagectomy using the Carina™ Surgical Platform (experimental group) or conventional thoracoscopic esophagectomy (control group). The primary endpoint is the rate of Textbook Outcome (TO) within 30 days post-operation. Secondary endpoints include operative parameters, quality of life, overall survival, disease-free survival, and health economic metrics.
Esophagectomy is a complex procedure for esophageal cancer. While conventional minimally invasive esophagectomy (MIE) reduces surgical trauma compared to open surgery, perioperative morbidity remains a challenge. The modular surgical robotic system (Carina™ Surgical Platform) provides 3D high-definition visualization, 7 degrees-of-freedom articulated instruments, tremor filtration, and flexible cart positioning designed to reduce arm collisions and expand surgical reach.
This prospective, multicenter, randomized controlled trial aims to recruit 160 patients with histologically confirmed resectable esophageal cancer across multiple clinical centers in China.
Eligible participants are stratified by center, surgical approach, and neoadjuvant therapy status, then randomly assigned (1:1) to:
All participants will undergo perioperative evaluations and structured follow-ups at 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years post-operation. The primary objective is to demonstrate the superiority of modular RAMIE over conventional MIE in achieving 30-day Textbook Outcome (TO), defined by R0 resection, lymph node yield ≥20, absence of intraoperative/severe postoperative complications, no ICU/MCU readmission, no 30-day surgical readmission, no anastomotic leak, length of stay \<14 days, and no in-hospital mortality. Health economic evaluations will include Incremental Cost-Effectiveness Ratio (ICER) and Incremental Cost-Utility Ratio (ICUR) based on EQ-5D-5L and QoL measurements.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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Exclusion Criteria:
Participants randomized to the experimental arm will undergo robot-assisted minimally invasive esophagectomy using the Carina™ modular surgical platform. The Carina™ platform is a modular robotic surgical system consisting of independently positioned patient carts, allowing flexible configuration according to procedural requirements. The surgical procedure will be performed by trained surgeons using the Carina™ system and its compatible surgical instruments to complete radical resection of resectable esophageal cancer.
Procedure: Modular Robot-Assisted Esophagectomy
Participants will undergo conventional minimally invasive esophagectomy using standard thoracoscopic and laparoscopic techniques for radical resection of resectable esophageal cancer. Commercially available conventional endoscopic surgical equipment, including 3-dimensional thoracoscopic systems routinely used at participating centers, may be used.
Procedure: Conventional Minimally Invasive Esophagectomy
Robot-assisted minimally invasive esophagectomy performed using the Carina™ modular surgical platform for radical resection of resectable esophageal cancer. The procedure will be performed by trained surgeons using the Carina™ system and compatible surgical instruments.
Conventional minimally invasive esophagectomy performed using standard thoracoscopic and laparoscopic surgical techniques for radical resection of resectable esophageal cancer. Commercially available conventional endoscopic surgical equipment, including 3-dimensional thoracoscopic systems routinely used at participating centers, may be used.
Textbook Outcome (TO) Rate
The proportion of participants achieving a textbook outcome within 30 days after surgery. Textbook outcome is defined as the composite achievement of all of the following: R0 resection; retrieval of at least 20 lymph nodes; no intraoperative complications; no Clavien-Dindo grade III or higher complications; no ICU/MCU readmission; no surgery-related readmission within 30 days after discharge; no anastomotic leakage of any ECCG grade; length of hospital stay less than 14 days; and no in-hospital death.
Time frame: Within 30 days after surgery
Surgical Preparation Time
Time from the initiation of anesthesia to the time when the primary surgeon is able to begin the surgical procedure.
Time frame: During surgery
Operative Time
Time from the start of the surgical procedure by the primary surgeon to completion of skin closure.
Time frame: During surgery
Total Operative Time
Time from the patient's entry into the operating room to completion of skin closure.
Time frame: During surgery
Intraoperative Blood Loss
Total estimated blood loss from the start of surgery to completion of wound closure, measured by visual estimation, suction volume, or weighing of blood-soaked materials.
Time frame: During surgery
Intraoperative Blood Transfusion Rate
Proportion of participants who receive a blood transfusion during surgery.
Time frame: During surgery
Postoperative Pain Score
Pain will be assessed using the modified Wong-Baker Faces Pain Rating Scale.
Time frame: At 24 hours after surgery and before hospital discharge
Conversion Rate
Proportion of participants requiring unplanned conversion of the assigned minimally invasive surgical approach to another surgical approach during the procedure. In the robot-assisted group, conversion to conventional thoracoscopic or open surgery will be recorded; in the conventional minimally invasive surgery group, conversion to open surgery will be recorded.
Time frame: During surgery
Postoperative Length of Hospital Stay
Length of hospital stay following surgery, calculated as the number of days from hospital admission to hospital discharge.
Time frame: Perioperative
EORTC Quality of Life Questionnaire Core 30 (QLQ-C30)
Quality of life will be assessed using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30).
Time frame: Baseline and at 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery
EORTC Quality of Life Questionnaire-Oesophageal Cancer Module (QLQ-OES18)
Quality of life will be assessed using the EORTC Quality of Life Questionnaire-Oesophageal Cancer Module (QLQ-OES18).
Time frame: Baseline and at 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery
Tumor Recurrence Rate
Proportion of participants with local recurrence or distant metastasis during the postoperative follow-up period.
Time frame: Up to 3 years after surgery
Overall Survival
Overall survival is defined as the proportion of participants who are alive during the postoperative follow-up period, regardless of postoperative complications or disease recurrence.
Time frame: Up to 3 years after surgery
Disease-Free Survival
Disease-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence, distant metastasis, or death from any cause.
Time frame: Up to 3 years after surgery
Perioperative Major Complication Rate
Proportion of participants experiencing perioperative complications of Clavien-Dindo grade III or higher.
Time frame: Up to 30 days after surgery
Postoperative Readmission Rate
Proportion of participants requiring hospital readmission due to complications related to the primary disease, disease recurrence, or adverse events.
Time frame: Up to 3 years after surgery
Incremental Cost-Effectiveness Ratio (ICER)
The incremental economic cost per additional unit of clinical effectiveness of robot-assisted minimally invasive esophagectomy compared with conventional minimally invasive esophagectomy. Effectiveness measures include textbook outcome, conversion rate, length of hospital stay, and tumor recurrence rate.
Time frame: At 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery
Incremental Cost-Utility Ratio (ICUR)
The incremental economic cost per additional quality-adjusted life-year (QALY) gained with robot-assisted minimally invasive esophagectomy compared with conventional minimally invasive esophagectomy. Health utility will be derived from EQ-5D-5L assessments.
Time frame: At 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 56 phase 3 interventional studies under Esophageal Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 106. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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