Outside the Cage (OTC) Robotic Esophagectomy

NCT ID: NCT06735638

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-01-01

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Out of the Cage Minimally Invasive Esophagectomy (OTC MIE)

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.

Group Type: EXPERIMENTAL

OTC MIE Esophagectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• Age < 18 years old
• Inability to consent to the study
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Moishe Liberman

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHUM

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Moishe Liberman

Role: CONTACT

moishe.liberman@umontreal.ca

514-890-8000

Facility Contacts

Moishe Liberman, MD, PhD

Role: primary

moishe.liberman@umontreal.ca

514 890-8000 ext. 26214

Other Identifiers

2025-12036

Identifier Type: -

Identifier Source: org_study_id