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NIF-Guided RAMIE Using ICG Versus OTE Feasibility RCT

Esophageal Cancer

In Canada, the incidence of esophageal cancer has been increasing over time, while surgical standards for esophageal resections have remained unchanged. Currently, the standard of surgical care for this cancer is Open Transthoracic Esophagectomy (OTE), a highly morbid operation that is associated with a complication rate of 60-80%, and a recovery period of many months. While Minimally Invasive Esophagectomy (MIE) has been developed it has not been adopted because it is highly complex, technically demanding, and has a longer operative time than OTE. With the advent of robotic platforms, Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) has recently emerged as a novel minimally invasive alternative to OTE. RAMIE utilizes the DaVinci Xi robotic surgical platform which offers superior dexterity, 3D-vision, and wristed surgical equipment. To date, case reports and small case series have demonstrated the safety of RAMIE, however it has not been performed yet in Canada, and there has been no randomized trial that has compared RAMIE to OTE. This study proposes to build the infrastructure for introducing RAMIE to Canada, while laying the foundations for a future randomized controlled trial which will compare it to OTE.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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.

Lieu de l'étude

St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Yogita S. Patel

Étude parrainée par
St. Joseph's Healthcare Hamilton
Participants recherchés
Plus d'informations
ID de l'étude: NCT04938973