Outside the Cage (OTC) Robotic Esophagectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Conversion rate — 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 — 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.

Trial sites (1)

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