Esophageal CancerRAMIE vs OTENCT04938973
NIF-Guided RAMIE Using ICG Versus OTE Feasibility RCT
A study testing Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) and Open Transthoracic Esophagectomy (OTE) in people with Esophageal Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) and Open Transthoracic Esophagectomy (OTE)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 18 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near-Infrared Fluorescence-Guided Robotic-Assisted Minimally Invasive Esophagectomy Using Indocyanine Green Dye Versus Open Transthoracic Esophagectomy: A Randomized Controlled Feasibility Trial
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.
Read the detailed description
In Canada, the incidence of esophageal cancer has been increasing over time. The treatment of patients with cancer of the esophagus is multi-modal, with surgery being the cornerstone of most treatment regimens. Operative treatment is usually performed through Open Transthoracic Esophagectomy (OTE), a highly morbid procedure that is associated with a complication rate of 60-80%, and a recovery period of many months. This standard is being challenged by a growing body of evidence demonstrating that a minimally invasive approach can reduce post-operative morbidity and improve quality-of-life, while still offering an adequate oncological outcome. The minimally invasive alternative to OTE is Minimally Invasive Esophagectomy (MIE). Although MIE has been shown to reduce the morbidity associated with esophagectomy, it has not been widely adopted. This failure of adoption is due to the high complexity of MIE; it is an exceedingly difficult operation, is associated with a very steep learning curve, and can take 8-10 hours to complete. As a result, less than 10% of esophageal cancer programs in Canada have adopted MIE, and there remains a need for a minimally invasive alternative to OTE. Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) has recently emerged as a minimally invasive alternative to OTE. RAMIE utilizes the DaVinci Xi robotic surgical platform which offers superior dexterity, 3D-vision, 7-degrees of freedom for range of motion, and near-infrared imaging for detection of blood vessels. As a result, RAMIE has succeeded where MIE has failed, and has been widely taken up in Europe and the United States.
To date, near-infrared fluorescence (NIF)-guided RAMIE using indocyanine green (ICG) dye has not been performed in Canada, and there has been no randomized trial that has compared NIF-guided RAMIE using ICG dye to OTE. In this study, we propose to build the infrastructure for introducing NIF-guided RAMIE using ICG dye to Canada, while laying the foundations for a future randomized controlled trial (RCT) which will compare it to OTE. This study is a Phase I, single center, prospective feasibility randomized controlled trial with two phases: Phase A: Learning Curve of NIF-guided RAMIE using ICG dye; and Phase B: A Randomized Controlled Feasibility Trial. In Phase A, 40 patients will be enrolled, and they will all undergo NIF-guided RAMIE using ICG dye. Evidence shows that a surgeon experienced in MIE requires experience of 40 cases to gain proficiency of RAMIE. In Phase B, 54 patients will be enrolled, and they will be randomized to either NIF-guided RAMIE using ICG dye, or OTE.
- Conditions
- Esophageal Cancer
- Being tested
- Robotic Assisted Minimally Invasive Esophagectomy (RAMIE), Open Transthoracic Esophagectomy (OTE)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)Procedure or surgery
Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.
Open Transthoracic Esophagectomy (OTE)Procedure or surgery
Open Transthoracic Esophagectomy (OTE) is the current standard of care.
Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)Device
Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Open Transthoracic Esophagectomy (OTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-Weeks Postoperative
Secondary outcomes (7)
Safety of the Operation, based on rates of perioperative complications
The safety of the operation based on rates of perioperative complications within 90-days of surgery, as defined by the Ottawa Thoracic Morbidity and Mortality Classification System (TMNM).
Measured: 12-Weeks Postoperative
Patient-Reported Health-Related Quality of Life - Pain Level
The Stanford Pain Scale will be administered to patients to assess pain (0 = no pain, 10 = worst pain)
Measured: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
Patient-Reported Health-Related Quality of Life - Quality of Life
EQ-5D-5L will be administered to patients to assess pain and quality of life. 5 items + overall health rating (0-100; 0 worst health imaginable, 100 best health imaginable)
Measured: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
Patient-Reported Health-Related Quality of Life - Reintegration into Normal Living
Reintegration to Normal Living Index will be administered to patients to assess quality of life. 11 items, each item scored from 1-10 (1 = no reintegration, 10 = complete reintegration)
Measured: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
Conversion from RAMIE to OTE
Rate of conversions from RAMIE to OTE
Measured: During Surgery
Length of Stay (LOS)
Length of hospital stay will be measured between the date of admission and date of discharge.
Measured: From Date of Admission to Date of Discharge, assessed up to 12-Weeks Postoperative
Length of Operation
Operative time will be measured by collecting the procedure start and procedure end time
Measured: During Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 May 2022
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Why it stopped: The study was closed due to adverse events because the adverse event rate was not lower than the adverse event rate in traditional open esophagectomy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Wael Hanna, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938973
- Sponsor's protocol ID
- SJHH_RAMIE_vs_OTE_Feasibility
- Acronym
- RAMIE vs OTE
- Status last verified
- Sep 2025
- First submitted
- 8 Jun 2021
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Fluorescence-Guided Robotic-Assisted Minimally Invasive Esophagectomy Using Indocyanine Green Dye Versus Open Transthoracic Esophagectomy: A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT04938973
- Acronym / sponsor ID
- RAMIE vs OTE / SJHH_RAMIE_vs_OTE_Feasibility
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed due to adverse events because the adverse event rate was not lower than the adverse event rate in traditional open esophagectomy.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Canada, the incidence of esophageal cancer has been increasing over time. The treatment of patients with cancer of the esophagus is multi-modal, with surgery being the cornerstone of most treatment regimens. Operative treatment is usually performed through Open Transthoracic Esophagectomy (OTE), a highly morbid procedure that is associated with a complication rate of 60-80%, and a recovery period of many months. This standard is being challenged by a growing body of evidence demonstrating that a minimally invasive approach can reduce post-operative morbidity and improve quality-of-life, while still offering an adequate oncological outcome. The minimally invasive alternative to OTE is Minimally Invasive Esophagectomy (MIE). Although MIE has been shown to reduce the morbidity associated with esophagectomy, it has not been widely adopted. This failure of adoption is due to the high complexity of MIE; it is an exceedingly difficult operation, is associated with a very steep learning curve, and can take 8-10 hours to complete. As a result, less than 10% of esophageal cancer programs in Canada have adopted MIE, and there remains a need for a minimally invasive alternative to OTE. Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) has recently emerged as a minimally invasive alternative to OTE. RAMIE utilizes the DaVinci Xi robotic surgical platform which offers superior dexterity, 3D-vision, 7-degrees of freedom for range of motion, and near-infrared imaging for detection of blood vessels. As a result, RAMIE has succeeded where MIE has failed, and has been widely taken up in Europe and the United States.
To date, near-infrared fluorescence (NIF)-guided RAMIE using indocyanine green (ICG) dye has not been performed in Canada, and there has been no randomized trial that has compared NIF-guided RAMIE using ICG dye to OTE. In this study, we propose to build the infrastructure for introducing NIF-guided RAMIE using ICG dye to Canada, while laying the foundations for a future randomized controlled trial (RCT) which will compare it to OTE. This study is a Phase I, single center, prospective feasibility randomized controlled trial with two phases: Phase A: Learning Curve of NIF-guided RAMIE using ICG dye; and Phase B: A Randomized Controlled Feasibility Trial. In Phase A, 40 patients will be enrolled, and they will all undergo NIF-guided RAMIE using ICG dye. Evidence shows that a surgeon experienced in MIE requires experience of 40 cases to gain proficiency of RAMIE. In Phase B, 54 patients will be enrolled, and they will be randomized to either NIF-guided RAMIE using ICG dye, or OTE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIF-Guided RAMIE using ICG Dye (Experimental Arm) | Experimental | Procedure: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE), Device: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)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. |
| Open Transthoracic Esophagectomy (OTE) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform. | Procedure or surgery | NIF-Guided RAMIE using ICG Dye (Experimental Arm) |
| Open Transthoracic Esophagectomy (OTE)Open Transthoracic Esophagectomy (OTE) is the current standard of care. | Procedure or surgery | Open Transthoracic Esophagectomy (OTE) |
| Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform. | Device | NIF-Guided RAMIE using ICG Dye (Experimental Arm) |
Primary outcome
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
A recruitment rate ≥70%, whereby participants partake in the study until first post-operative follow-up, would be considered acceptable.
7 secondary outcomes
Safety of the Operation, based on rates of perioperative complications
Time frame: 12-Weeks Postoperative
Patient-Reported Health-Related Quality of Life - Pain Level
Time frame: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
Patient-Reported Health-Related Quality of Life - Quality of Life
Time frame: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
Patient-Reported Health-Related Quality of Life - Reintegration into Normal Living
Time frame: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
Conversion from RAMIE to OTE
Time frame: During Surgery
Length of Stay (LOS)
Time frame: From Date of Admission to Date of Discharge, assessed up to 12-Weeks Postoperative
Length of Operation
Time frame: During Surgery
Results and safety
The study was stopped early (reason given: The study was closed due to adverse events because the adverse event rate was not lower than the adverse event rate in traditional open esophagectomy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) and Open Transthoracic Esophagectomy (OTE) in people with Esophageal Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was closed due to adverse events because the adverse event rate was not lower than the adverse event rate in traditional open esophagectomy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.