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Stopped early

NIF-Guided RAMIE Using ICG Versus OTE Feasibility RCT

NCT04938973 · St. Joseph's Healthcare Hamilton · Updated 17 Sept 2025

What is being tested
Robotic Assisted Minimally Invasive Esophagectomy (RAMIE); Open Transthoracic Esophagectomy (OTE); Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)
For
Esophageal Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 24 people. The full rules are on the registry page.
Where
Canada
When
Starts or started 1 May 2022, ends 18 June 2025. Registered 25 June 2021.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT04938973

Sites

  • St. Joseph's Healthcare HamiltonHamilton, Ontario, Canada