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Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

RecruitingPhase 3Ages 18 Years - anyAllRuijin Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.
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What it tests

  • Modular Robot-Assisted Esophagectomy
  • Conventional Minimally Invasive Esophagectomy
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Where

1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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