Robotic Surgery for Esophageal Cancer

Overseen By Moishe Liberman

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Age < 18, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robotic surgery method for treating esophageal cancer. The goal is to determine if this method, called OTC MIE esophagectomy, can reduce chest pain and improve recovery compared to the usual surgery. Participants will undergo surgery using either the new robotic approach or the traditional one. The trial seeks individuals with stage I, II, or III esophageal cancer who plan to have surgery. As a Phase 1 trial, this research focuses on understanding how this new surgical method works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this robotic approach is safe for esophageal cancer surgery?

Research shows that the "Out of the Cage" (OTC) minimally invasive esophagectomy (MIE) is a new robotic surgery being tested for esophageal cancer. This method aims to reduce chest pain by avoiding cuts between the ribs.

Specific safety data for this new technique is not yet available, but robotic surgeries in general often result in fewer complications, such as less blood loss and fewer lung issues. One study on MIE found a low short-term death rate of about 1.68%, suggesting that MIE surgeries are generally safe and well-tolerated.

As the trial is in its early stages, the primary focus is on ensuring the approach is safe for participants. Any possible side effects and how patients handle the surgery will be closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Out of the Cage Minimally Invasive Esophagectomy (OTC MIE) for esophageal cancer because it offers a novel surgical approach. Unlike the traditional minimally invasive esophagectomy that uses intercostal incisions, the OTC MIE employs 1 to 4 subcostal ports, which are tailored to the patient's anatomy. This approach aims to reduce trauma to the chest wall and potentially decrease post-operative pain and recovery time. By minimizing the invasiveness of the procedure, the OTC MIE could enhance patient outcomes and make recovery smoother.

What evidence suggests that this robotic surgery is effective for esophageal cancer?

Research has shown that a minimally invasive esophagectomy (MIE) can extend the lives of esophageal cancer patients compared to traditional open surgery. Studies have found that MIE leads to better long-term outcomes, such as overall survival and being cancer-free, particularly in older patients. In this trial, participants will undergo the "Out of the Cage" (OTC) method, a variation of MIE that avoids the usual chest incisions, potentially reducing chest pain and speeding up recovery. Although data on OTC remains limited, the success of MIE in general suggests that this new method could be promising. Early results from similar techniques are encouraging for improved surgical outcomes and patient comfort. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with esophageal cancer. Participants will be chosen to undergo either a new robotic surgery technique called OTC MIE or the traditional minimally invasive esophagectomy (MIE). The study aims to recruit 31 patients.

Inclusion Criteria

I have stage I, II, or III esophageal cancer and am scheduled for a minimally invasive surgery.

Exclusion Criteria

I am unable to give consent for the study myself.

Pregnancy

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive esophagectomy using the Out of the Cage (OTC) robotic approach

Intraoperative

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative outcomes, including chest pain and recovery metrics

30 days

Regular in-person assessments

Follow-up

Participants are monitored for long-term safety and effectiveness of the novel approach

1 year

What Are the Treatments Tested in This Trial?

Interventions

• OTC MIE Esophagectomy

Trial Overview The trial is testing a novel non-intercostal approach to robotic surgery, known as OTC MIE Esophagectomy, against the standard MIE procedure. It focuses on comparing postoperative outcomes like chest pain and recovery speed between the two methods.

How Is the Trial Designed?

Group I: Out of the Cage Minimally Invasive Esophagectomy (OTC MIE) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06735638

NCT06735638 | Outside the Cage (OTC) Robotic Esophagectomy The goal of this clinical trial is to evaluate the feasibility and safety of a novel non-intercostal robotic approach for minimally invasive esophagectomy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12559150/

Long-term outcomes of minimally invasive esophagectomy ... In conclusion, our study demonstrates that MIE is associated with significantly improved OS and DFS compared to OE in older patients with ESCC.

3. oaepublish.com oaepublish.com/articles/2574-1225.2025.26

Advances in minimally invasive esophagectomy (MIE) Five-year survival outcomes of hybrid minimally invasive esophagectomy in esophageal cancer: results of the MIRO randomized clinical trial.

4. vats.amegroups.org vats.amegroups.org/article/view/6039/html

Oncologic outcomes in minimally invasive esophagectomy for ... MIE offers at least equivalent outcomes in terms of resection margins and lymph node harvest and long-term survival data.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4103614/

Outcomes After Minimally Invasive Esophagectomy Outcomes after diagnosis of esophageal cancer are suboptimal, with a 5-year survival rate of 15% to 25%, although an improvement in survival, associated with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06735638

Outside the Cage (OTC) Robotic Esophagectomy 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.

7. withpower.com withpower.com/trial/robotic-surgery-for-esophageal-cancer-94088

Robotic Surgery for Esophageal Cancer · Info for Participants 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 ...