Outside the Cage (OTC) Robotic Esophagectomy

Outside the Cage (OTC) Robotic Esophagectomy , Single Center Phase I 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: OTC MIE Esophagectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Moishe Liberman; Phone Number: 514-890-8000; Email: moishe.liberman@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X0A9
      • CHUM
      • Contact: Moishe Liberman, MD, PhD; Phone Number: 26214 514 890-8000; Email: moishe.liberman@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion rate	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	Through study completion, an average of 1 year
30-day mortality	Safety will be evaluated by 30-day mortality. Any dead occurring during the hospital stay or within 30 days after discharge will be registered.	30 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of hospital stay	Through study completion, an average of 1 year
Operative time	Surgical operative time including robot positioning	Intraoperative
Estimated blood loss	Registered by the OR nurse team	Intraoperative
Serious adverse events	Complications derived from the operation that altered the pathway	Through study completion, an average of 1 year
Perioperative complications	Complications including intraoperative and postoperative occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification	Through study completion, an average of 1 year
Postoperative pain	Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome)	Through study completion, an average of 1 year
Quality of recovery	Assessment of postoperative recovery using Quality Of Recovery (QOR-15) questionnaire between 0 and 10 (0: Better outcome and 10: Worst outcome)	Through study completion, an average of 1 year
Analgesic complementation requirement	Number of participants who need of adding analgesia medication out of the analgesic pathway used in our center for conventional RATS/VATS	Through study completion, an average of 1 year
Evaluate Chronic Pain	Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome). Chronic pain of OTC RATS lobectomy patients will be compared to that of VATS lobectomy patients, for which the data will also be collected and analysed retrospectively.	Through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Robotic-assisted surgery; Phase I clinical trial; Esophageal cancer; Enhanced recovery after surgery (ERAS); Minimally invasive esophagectomy (MIE); Outside the Cage (OTC) technique; Robotic-assisted thoracic surgery (RATS); Non-intercostal approach
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Genetic Diseases, X-Linked; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Amino Acid Metabolism, Inborn Errors; Urea Cycle Disorders, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Esophageal Neoplasms; Ornithine Carbamoyltransferase Deficiency Disease
• Other Study ID Numbers: 2025-12036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No