NIF-Guided RAMIE Using ICG Versus OTE Feasibility RCT

NCT04938973 | Terminated DMC

• 1 other identifier: SJHH_RAMIE_vs_OTE_Feasibility
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The feasibility of a large-scale RCT, as measured by the number of patients willing to participate in the study.

  A recruitment rate ≥70%, whereby participants partake in the study until first post-operative follow-up, would be considered acceptable.

  3-Weeks Postoperative

Secondary Outcomes (7)

• Safety of the Operation, based on rates of perioperative complications

  12-Weeks Postoperative

• Patient-Reported Health-Related Quality of Life - Pain Level

  Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative

• Patient-Reported Health-Related Quality of Life - Quality of Life

  Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative

• Patient-Reported Health-Related Quality of Life - Reintegration into Normal Living

  Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative

• Conversion from RAMIE to OTE

  During Surgery

Study Arms (2)

NIF-Guided RAMIE using ICG Dye (Experimental Arm)

EXPERIMENTAL

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.

Procedure: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE); Device: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)

Open Transthoracic Esophagectomy (OTE)

ACTIVE COMPARATOR

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.

Procedure: Open Transthoracic Esophagectomy (OTE)

Interventions

Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) PROCEDURE

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

NIF-Guided RAMIE using ICG Dye (Experimental Arm)

Open Transthoracic Esophagectomy (OTE) PROCEDURE

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

Open Transthoracic Esophagectomy (OTE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 25, 2021
• Study Start: May 1, 2022
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)