Esophageal CancerPhase 1NCT06735638
Outside the Cage (OTC) Robotic Esophagectomy
A Phase 1 study testing OTC MIE Esophagectomy in people with Esophageal Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate the feasibility and safety of a novel non-intercostal robotic approach for minimally invasive esophagectomy (OTC MIE) in the treatment of esophageal cancer. 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?
- OTC MIE Esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2027to 1 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- All patients with clinical stage I, II, or III esophageal cancer (cT1-3N0-2M0) scheduled to undergo minimally invasive esophagectomy (MIE) by VATS/RATS at the CHUM.
Who cannot join
- Age < 18 years old
- Inability to consent to the study
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
CHUM
Montreal, Quebec, H2X0A9
Moishe Liberman, MD, PhD, 514 890-8000 ext. 26214, moishe.liberman@umontreal.ca
About this study
Official title: Outside the Cage (OTC) Robotic Esophagectomy , Single Center Phase I Trial
The goal of this clinical trial is to evaluate the feasibility and safety of a novel non-intercostal robotic approach for minimally invasive esophagectomy (OTC MIE) in the treatment of esophageal cancer. This study aims to determine whether OTC MIE reduces the risk of acute and chronic chest pain compared to traditional minimally invasive esophagectomy (MIE) and improves postoperative outcomes for patients. Participants will undergo either the OTC MIE procedure or a traditional MIE approach as part of their treatment for esophageal cancer. Postoperative outcomes, including chest pain and recovery metrics, will be closely monitored. Follow-up assessments will be conducted to evaluate the long-term safety and effectiveness of the novel approach. The investigators aim to recruit 31 patients.
Read the detailed description
Esophageal cancer is the seventh most common cancer diagnosis worldwide, with approximately 604,000 new cases in 2022. Esophagectomy remains a cornerstone of esophageal cancer treatment, typically combined with perioperative chemoradiation for locally advanced disease. The procedure can be performed using various approaches, including open surgery and minimally invasive esophagectomy (MIE). MIE combines laparoscopy with thoracic techniques such as video-assisted thoracic surgery (VATS) or robotic-assisted surgery (RA), aiming to minimize trauma and improve both postoperative and long-term outcomes.
While VATS and RA have demonstrated reduced cardiopulmonary morbidity and mortality compared to open esophagectomy, both methods still involve intercostal incisions. These incisions can cause trauma to intercostal nerves and bundles, potentially leading to acute and chronic postoperative chest pain. The evolution of minimally invasive techniques in thoracic and lung surgery has focused on reducing the size and number of incisions to minimize surgical trauma. However, even with these advancements, intercostal instrumentation remains a source of significant postoperative complications.
Our group has developed a novel non-intercostal robotic approach for thoracic surgery called Outside the Cage (OTC) RATS. This technique was successfully implemented in over 60 lung resections, with the first published series showing promising outcomes, including feasibility, safety, and reduced postoperative pain. Additionally, results from a phase I clinical trial (NCT05832112) confirmed the safety and feasibility of this approach, with trends indicating faster recovery and less postoperative pain. Based on this experience, we recently performed the world's first OTC esophagectomy and have since refined the technique with successful outcomes, including no conversions to open surgery, transfusions, or major complications.
This study is a prospective pilot phase I trial designed to assess the feasibility and safety of OTC MIE in patients treated for esophageal cancer. Patients eligible for participation will include those already scheduled for MIE based on clinical indications such as tumor size, location, and individual characteristics. By avoiding intercostal instrumentation, we hypothesize that the OTC MIE approach will positively impact postoperative outcomes, enhancing recovery and reducing complications.
The primary objective of this study is to evaluate the feasibility of performing OTC MIE. The secondary objective is to systematically analyze the safety and postoperative recovery of patients undergoing this technique.
This trial is timely given our institution's extensive experience with both traditional MIE and OTC RATS. The results of this study could have significant implications for clinical practice by demonstrating the benefits of a non-intercostal approach for esophageal cancer surgery, potentially improving patient recovery and reducing the burden on healthcare systems.
- Conditions
- Esophageal Cancer
- Being tested
- OTC MIE Esophagectomy
- Keywords
- Esophageal cancer, Minimally invasive esophagectomy (MIE), Robotic-assisted surgery, Phase I clinical trial, Outside the Cage (OTC) technique, Robotic-assisted thoracic surgery (RATS), Enhanced recovery after surgery (ERAS), Non-intercostal approach
- Medical subject headings
- Esophageal Neoplasms, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTC MIE EsophagectomyProcedure or surgery
Consenting patients will undergo minimally invasive esophagectomy (MIE) using the Out of the Cage (OTC) robotic-assisted technique. The procedure will follow the exact standard steps of traditional VATS/RATS esophagectomy, except the thoracic ports will be placed in the subcostal plane. The number of ports (1-4) will be determined based on the patient and case characteristics.
The Da Vinci Xi® surgical system will be used to perform the thoracic portion of the esophagectomy through subcostal ports using the standard technique. Once the procedure is completed, the robotic arms and ports will be removed from the chest, and figure-of-8 stitches with non-absorbable sutures will be placed to close the diaphragm at the port sites. A 24 Fr soft chest tube will be left in place, as per standard VATS/RATS esophagectomy protocols. Incisions will be closed in the standard manner.
| Study group | Role | What they receive |
|---|---|---|
| Out of the Cage Minimally Invasive Esophagectomy (OTC MIE) | Experimental | Consented patients will undergo minimally invasive esophagectomy (MIE) using the Out of the Cage (OTC) robotic approach. This approach follows the standard procedural steps typically used in minimally invasive esophagectomy (e.g., laparoscopy and robotic-assisted thoracic surgery), with the primary difference being the incisions. Instead of intercostal incisions, the thoracic component of the procedure will be performed using 1 to 4 subcostal ports, tailored to the patient's anatomy and the case requirements. Receives: Procedure: OTC MIE Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Feasibility will be evaluated by completion of the procedure without conversion of the approach or technique. Any change in the treatment plan requiring the use of intercostal ports, conversion to conventional minimally invasive thoracic surgery through intercostal incisions, or conversion to open surgery
Measured: Through study completion, an average of 1 year
30-day mortality
Safety will be evaluated by 30-day mortality. Any dead occurring during the hospital stay or within 30 days after discharge will be registered.
Measured: 30 days after discharge
Secondary outcomes (9)
Length of stay
Length of hospital stay
Measured: Through study completion, an average of 1 year
Operative time
Surgical operative time including robot positioning
Measured: Intraoperative
Estimated blood loss
Registered by the OR nurse team
Measured: Intraoperative
Postoperative pain
Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome)
Measured: Through study completion, an average of 1 year
Quality of recovery
Assessment of postoperative recovery using Quality Of Recovery (QOR-15) questionnaire between 0 and 10 (0: Better outcome and 10: Worst outcome)
Measured: Through study completion, an average of 1 year
Analgesic complementation requirement
Number of participants who need of adding analgesia medication out of the analgesic pathway used in our center for conventional RATS/VATS
Measured: Through study completion, an average of 1 year
Serious adverse events
Complications derived from the operation that altered the pathway
Measured: Through study completion, an average of 1 year
Perioperative complications
Complications including intraoperative and postoperative occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification
Measured: Through study completion, an average of 1 year
Evaluate Chronic Pain
Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome).
Chronic pain of OTC RATS lobectomy patients will be compared to that of VATS lobectomy patients, for which the data will also be collected and analysed retrospectively.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moishe Liberman, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735638
- Sponsor's protocol ID
- 2025-12036
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outside the Cage (OTC) Robotic Esophagectomy , Single Center Phase I Trial
- ClinicalTrials.gov ID
- NCT06735638
- Acronym / sponsor ID
- 2025-12036
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Minimally invasive esophagectomy (MIE), Robotic-assisted surgery, Phase I clinical trial, Outside the Cage (OTC) technique, Robotic-assisted thoracic surgery (RATS), Enhanced recovery after surgery (ERAS), Non-intercostal approach
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Dec 2024 (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.
The goal of this clinical trial is to evaluate the feasibility and safety of a novel non-intercostal robotic approach for minimally invasive esophagectomy (OTC MIE) in the treatment of esophageal cancer. This study aims to determine whether OTC MIE reduces the risk of acute and chronic chest pain compared to traditional minimally invasive esophagectomy (MIE) and improves postoperative outcomes for patients. Participants will undergo either the OTC MIE procedure or a traditional MIE approach as part of their treatment for esophageal cancer. Postoperative outcomes, including chest pain and recovery metrics, will be closely monitored. Follow-up assessments will be conducted to evaluate the long-term safety and effectiveness of the novel approach. The investigators aim to recruit 31 patients.
Detailed description
Esophageal cancer is the seventh most common cancer diagnosis worldwide, with approximately 604,000 new cases in 2022. Esophagectomy remains a cornerstone of esophageal cancer treatment, typically combined with perioperative chemoradiation for locally advanced disease. The procedure can be performed using various approaches, including open surgery and minimally invasive esophagectomy (MIE). MIE combines laparoscopy with thoracic techniques such as video-assisted thoracic surgery (VATS) or robotic-assisted surgery (RA), aiming to minimize trauma and improve both postoperative and long-term outcomes.
While VATS and RA have demonstrated reduced cardiopulmonary morbidity and mortality compared to open esophagectomy, both methods still involve intercostal incisions. These incisions can cause trauma to intercostal nerves and bundles, potentially leading to acute and chronic postoperative chest pain. The evolution of minimally invasive techniques in thoracic and lung surgery has focused on reducing the size and number of incisions to minimize surgical trauma. However, even with these advancements, intercostal instrumentation remains a source of significant postoperative complications.
Our group has developed a novel non-intercostal robotic approach for thoracic surgery called Outside the Cage (OTC) RATS. This technique was successfully implemented in over 60 lung resections, with the first published series showing promising outcomes, including feasibility, safety, and reduced postoperative pain. Additionally, results from a phase I clinical trial (NCT05832112) confirmed the safety and feasibility of this approach, with trends indicating faster recovery and less postoperative pain. Based on this experience, we recently performed the world's first OTC esophagectomy and have since refined the technique with successful outcomes, including no conversions to open surgery, transfusions, or major complications.
This study is a prospective pilot phase I trial designed to assess the feasibility and safety of OTC MIE in patients treated for esophageal cancer. Patients eligible for participation will include those already scheduled for MIE based on clinical indications such as tumor size, location, and individual characteristics. By avoiding intercostal instrumentation, we hypothesize that the OTC MIE approach will positively impact postoperative outcomes, enhancing recovery and reducing complications.
The primary objective of this study is to evaluate the feasibility of performing OTC MIE. The secondary objective is to systematically analyze the safety and postoperative recovery of patients undergoing this technique.
This trial is timely given our institution's extensive experience with both traditional MIE and OTC RATS. The results of this study could have significant implications for clinical practice by demonstrating the benefits of a non-intercostal approach for esophageal cancer surgery, potentially improving patient recovery and reducing the burden on healthcare systems.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out of the Cage Minimally Invasive Esophagectomy (OTC MIE) | Experimental | Procedure: OTC MIE EsophagectomyConsented patients will undergo minimally invasive esophagectomy (MIE) using the Out of the Cage (OTC) robotic approach. This approach follows the standard procedural steps typically used in minimally invasive esophagectomy (e.g., laparoscopy and robotic-assisted thoracic surgery), with the primary difference being the incisions. Instead of intercostal incisions, the thoracic component of the procedure will be performed using 1 to 4 subcostal ports, tailored to the patient's anatomy and the case requirements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with clinical stage I, II, or III esophageal cancer (cT1-3N0-2M0) scheduled to undergo minimally invasive esophagectomy (MIE) by VATS/RATS at the CHUM.
Key exclusion criteria (3 listed)
- Age < 18 years old
- Inability to consent to the study
- Pregnancy
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 |
|---|---|---|
| OTC MIE EsophagectomyConsenting patients will undergo minimally invasive esophagectomy (MIE) using the Out of the Cage (OTC) robotic-assisted technique. The procedure will follow the exact standard steps of traditional VATS/RATS esophagectomy, except the thoracic ports will be placed in the subcostal plane. The number of ports (1-4) will be determined based on the patient and case characteristics. The Da Vinci Xi® surgical system will be used to perform the thoracic portion of the esophagectomy through subcostal ports using the standard technique. Once the procedure is completed, the robotic arms and ports will be removed from the chest, and figure-of-8 stitches with non-absorbable sutures will be placed to close the diaphragm at the port sites. A 24 Fr soft chest tube will be left in place, as per standard VATS/RATS esophagectomy protocols. Incisions will be closed in the standard manner. | Procedure or surgery | Out of the Cage Minimally Invasive Esophagectomy (OTC MIE) |
Primary outcome
Conversion rate
Time frame: Through study completion, an average of 1 year
Feasibility will be evaluated by completion of the procedure without conversion of the approach or technique. Any change in the treatment plan requiring the use of intercostal ports, conversion to conventional minimally invasive thoracic surgery through intercostal incisions, or conversion to open surgery
30-day mortality
Time frame: 30 days after discharge
Safety will be evaluated by 30-day mortality. Any dead occurring during the hospital stay or within 30 days after discharge will be registered.
9 secondary outcomes
Length of stay
Time frame: Through study completion, an average of 1 year
Operative time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Postoperative pain
Time frame: Through study completion, an average of 1 year
Quality of recovery
Time frame: Through study completion, an average of 1 year
Analgesic complementation requirement
Time frame: Through study completion, an average of 1 year
Serious adverse events
Time frame: Through study completion, an average of 1 year
Perioperative complications
Time frame: Through study completion, an average of 1 year
Evaluate Chronic Pain
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTC MIE Esophagectomy in people with Esophageal Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Mar 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moishe Liberman (514-890-8000, moishe.liberman@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 18 Mar 2026.