Modular Robot-Assisted Esophagectomy vs. Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized phase 3 trial compares modular robotic-assisted esophagectomy with conventional minimally invasive esophagectomy in patients with resectable esophageal cancer. Participants are randomized 1:1 to receive either RAMIE with the Carina platform or standard MIE, with the primary endpoint being the 30-day Textbook Outcome. Secondary endpoints include operative metrics, quality of life, survival, and health economic measures. The study will enroll about 160 participants across several Chinese centers and follow them at multiple time points up to 3 years post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Hecheng Li, MD, PhD, FACS, FRCS — Ruijin Hospital
• Study coordinator: Yuqin Cao, MD, MSc
• Email: caoyuqin314@outlook.com
• Phone: +86 64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.