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Outside the Cage (OTC) Robotic Esophagectomy

NCT06735638 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-03-18

No results posted yet for this study

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. 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.

Conditions

  • Esophageal Cancer

Interventions

PROCEDURE

OTC MIE Esophagectomy

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.

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735638 on ClinicalTrials.gov