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NCT07888140RecruitingPhase 3

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

A Prospective, Multicenter, Randomized Controlled Trial Comparing Modular Robot-Assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Esophageal Cancer

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
160 (estimated)
First submitted
9 Sept 2026
Start date
15 Oct 2026
Primary completion date
30 Oct 2028
Lead sponsor
Ruijin Hospital
NCT number
NCT07888140

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 160
  • From 15 Oct 2026 to the primary completion date, 30 Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe coagulation dysfunction that precludes surgery;
  • 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;

Other illness

  • 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;
  • Uncontrolled epilepsy or psychiatric disorders, inability to understand study requirements, or inability to complete the planned follow-up;
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.

Other

  • Body mass index (BMI) \<18.5 kg/m²;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.