Esophageal CancerPhase 3mRAMIE2026NCT07888140
Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
A Phase 3 study testing Modular Robot-Assisted Esophagectomy and Conventional Minimally Invasive Esophagectomy in people with Esophageal Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Modular Robot-Assisted Esophagectomy and Conventional Minimally Invasive Esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 30 Oct 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, regardless of sex;
- Histologically confirmed resectable malignant esophageal tumor, without invasion of adjacent vital organs and without evidence of distant metastasis on imaging examinations (including at least one of MRI, PET-CT, or CT);
- Patients may have received neoadjuvant therapy;
- Willing and able to provide written informed consent.
Who cannot join
- Body mass index (BMI) <18.5 kg/m²;
- History of thoracic surgery or thoracic trauma;
- History of extensive intra-abdominal adhesions, severe systemic infection, or metastatic disease;
- History of other malignancies, except for cured low-risk tumors such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, or carcinoma in situ of the cervix;
- History of gastric surgery or inability to undergo gastric conduit reconstruction for esophageal replacement;
- Significant dysfunction of other organ systems or comorbidities, including severe cardiac, pulmonary, neurological, hepatic, or renal dysfunction, that, in the investigator's judgment, precludes tolerance of surgery;
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- Severe coagulation dysfunction that precludes surgery;
- Uncontrolled epilepsy or psychiatric disorders, inability to understand study requirements, or inability to complete the planned follow-up;
- Participation in another clinical study during its observation period, or previous participation in a clinical study that, in the investigator's judgment, may potentially affect the outcomes of this study;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200230
Yuqin Cao, MD, MSc, +86-21-64370045 ext. 666111, caoyuqin314@outlook.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial Comparing Modular Robot-Assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Esophageal Cancer
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.
Read the detailed description
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:
- Experimental Arm: Modular robotic-assisted esophagectomy using the Carina™ Surgical Platform.
- Control Arm: Conventional 3D thoracoscopic esophagectomy.
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.
- Conditions
- Esophageal Cancer
- Being tested
- Modular Robot-Assisted Esophagectomy, Conventional Minimally Invasive Esophagectomy
- Keywords
- Esophageal Neoplasms, Esophagectomy, Robot-Assisted Surgery, Modular Robotic Surgery, Minimally Invasive Surgical Procedures, Carina Surgical Platform, Textbook Outcome
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular Robot-Assisted EsophagectomyProcedure or surgery
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 EsophagectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Carina™ Robot-Assisted Surgery | Experimental | 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. Receives: Procedure: Modular Robot-Assisted Esophagectomy |
| Conventional Minimally Invasive Surgery | Active comparator | 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. Receives: Procedure: Conventional Minimally Invasive Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (13)
Surgical Preparation Time
Time from the initiation of anesthesia to the time when the primary surgeon is able to begin the surgical procedure.
Measured: During surgery
Operative Time
Time from the start of the surgical procedure by the primary surgeon to completion of skin closure.
Measured: During surgery
Total Operative Time
Time from the patient's entry into the operating room to completion of skin closure.
Measured: 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.
Measured: During surgery
Intraoperative Blood Transfusion Rate
Proportion of participants who receive a blood transfusion during surgery.
Measured: During surgery
Postoperative Pain Score
Pain will be assessed using the modified Wong-Baker Faces Pain Rating Scale.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multicenter, open-label, parallel-group, 1:1 randomized controlled superiority trial designed to evaluate the safety, efficacy, and health economic outcomes of modular robot-assisted esophagectomy compared with conventional thoracoscopic esophagectomy in patients with resectable esophageal cancer.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Jiangsu Provincial People's Hospital, Union hospital of Fujian Medical University
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
- Investigators
- Hecheng Li, MD, PhD, FACS, FRCS, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888140
- Sponsor's protocol ID
- RTS-032
- Acronym
- mRAMIE2026
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No