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NIF-Guided RAMIE

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT04938973

Conditions

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)

Open Transthoracic Esophagectomy (OTE)

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)

Study Details

Brief 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

Study ID

NCT04938973

Start date

May 1, 2022

Status verified date

May, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NIF-Guided RAMIE using ICG Dye (Experimental Arm)

The patient will undergo NIF-guided RAMIE using ICG dye using the standard Ivor-Lewis approach. This will be a two-stage operation involving a first stage through a 5-port robotic approach through the abdomen to achieve a proximal gastrectomy and D2 nodal dissection. A feeding jejunostomy would not be inserted, as per the enhanced recovery pathway for esophagectomy. In addition, the vascularization of the conduit can be confirmed using the near-infrared camera of the robot with the ICG dye. The second stage of the operation will involve a 4-port robotic approach through the right chest to achieve thoracic nodal dissection, esophagectomy, and a hand-sewn anastomosis between the residual esophagus and the gastric conduit at the level of the azygous vein. During this second stage of the operation, NIF with ICG dye will be used to visualize the vascular supply of the gastric conduit, and assess the gastric conduit for any perfusions to potentially reduce anastomotic leaks.

active comparator: Open Transthoracic Esophagectomy (OTE)

The patient will undergo OTE using the standard Ivor-Lewis approach. This is a two-stage operation involving a first stage through laparotomy, proximal gastrectomy, D2 nodal dissection, and insertion of feeding jejunostomy. The second stage of the operation will involve a right thoracotomy, thoracic nodal dissection, esophagectomy, and a stapled anastomosis between the residual esophagus and the gastric conduit at the level of the azygous vein.

Interventions

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)

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

Open Transthoracic Esophagectomy (OTE)

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

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)

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

Primary outcome measure

  • The feasibility of a large-scale RCT, as measured by the number of patients willing to participate in the study. [ Time Frame: 3-Weeks Postoperative ]

Central Contacts and Locations

Central contacts

Yogita S. Patel

905-522-1155patelys@mcmaster.ca

Jacob A. Alaichi

905-522-1155alaichij@mcmaster.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N4A6

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

May 31, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2025-05-31.