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

31 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment OTC MIE Esophagectomy for esophageal cancer?

Research shows that minimally invasive esophagectomy (MIE), which includes robotic-assisted techniques, generally leads to better outcomes compared to traditional open surgery. This includes improved recovery and potentially better survival rates for patients with esophageal cancer. ^{1 2 3 4 5}

How does robotic-assisted minimally invasive esophagectomy differ from other treatments for esophageal cancer?

Robotic-assisted minimally invasive esophagectomy (MIE) for esophageal cancer is unique because it uses robotic technology to enhance surgical precision and ergonomics, potentially reducing respiratory complications compared to traditional open surgery. This approach allows for better surgical dissection with 3D imaging and robotic arms, which may improve patient outcomes and recovery. ^{1 5 6 7 8}

What is the purpose of this 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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparative outcomes of minimally invasive and robotic-assisted esophagectomy. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

Minimally invasive esophagectomy for esophageal cancer: an updated review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparing Perioperative Mortality and Morbidity of Minimally Invasive Esophagectomy Versus Open Esophagectomy for Esophageal Cancer: A Nationwide Retrospective Analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative Outcomes of Minimally Invasive Esophagectomy Versus Open Esophagectomy: A Meta-Analysis of Randomized Controlled Trials. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes, quality of life, and survival after esophagectomy for squamous cell carcinoma: A propensity score-matched comparison of operative approaches. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of esophageal cancer: laparoscopic staging to robotic esophagectomy. [2019]

7. China pubmed.ncbi.nlm.nih.gov

Robotic esophagectomy. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Robotic-assisted minimally invasive esophagectomy for treatment of esophageal carcinoma. [2022]