Minimally invasive surgery for esophageal cancer using robotic assistance
Near-Infrared Fluorescence-Guided Robotic-Assisted Minimally Invasive Esophagectomy Using Indocyanine Green Dye Versus Open Transthoracic Esophagectomy: A Randomized Controlled Feasibility Trial
This study is testing a new robotic surgery method for esophageal cancer to see if it is safer and helps patients recover faster than the traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT04938973 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) compared to the traditional Open Transthoracic Esophagectomy (OTE) for patients with esophageal cancer. The study aims to assess the safety and effectiveness of RAMIE, which utilizes advanced robotic technology to enhance surgical precision and reduce recovery time. Participants will be selected based on their clinical stage and suitability for minimally invasive surgery, as determined by a multidisciplinary team. The trial is being conducted at St. Joseph's Healthcare Hamilton in Canada.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with clinical Stage I, II, or III esophageal cancer who are deemed suitable for minimally invasive surgery.
Not a fit: Patients with clinical Stage IV esophageal cancer or those not suitable for minimally invasive surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce surgical complications and recovery time for patients with esophageal cancer.
How similar studies have performed: While RAMIE has shown promise in small case series, this is one of the first trials assessing its feasibility in Canada, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Clinical Stage I, II, or III esophageal cancer, who are candidates for surgery after discussion in multidisciplinary tumor board. * Candidates for minimally invasive surgery as determined by the operating surgeon. Exclusion Criteria: * Hypersensitivity or allergy to ICG, sodium iodide, or iodine * Women who are currently pregnant or are breastfeeding; or women of childbearing potential who are not currently taking adequate birth control * Clinical Stage IV esophageal cancer. * Not a candidate for minimally invasive surgery as determined by the operating surgeon.
Where this trial is running
Hamilton, Ontario
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Yogita S. Patel
- Email: patelys@mcmaster.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.