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NIF-Guided RAMIE Using ICG Versus OTE Feasibility RCT

NCT04938973 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-17

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Cancer

Interventions

PROCEDURE

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.

PROCEDURE

Open Transthoracic Esophagectomy (OTE)

Open Transthoracic Esophagectomy (OTE) is the current standard of care.

DEVICE

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2025-06-18
Completion
2025-06-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938973 on ClinicalTrials.gov