Outside the Cage (OTC) Robotic Esophagectomy

Phase 1

Not yet recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT06735638
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Study Start: 2025-03-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Length of stay	Through study completion, an average of 1 year	Length of hospital stay
Operative time	Intraoperative	Surgical operative time including robot positioning
Estimated blood loss	Intraoperative	Registered by the OR nurse team
Postoperative pain	Through study completion, an average of 1 year	Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome)
Quality of recovery	Through study completion, an average of 1 year	Assessment of postoperative recovery using Quality Of Recovery (QOR-15) questionnaire between 0 and 10 (0: Better outcome and 10: Worst outcome)
Analgesic complementation requirement	Through study completion, an average of 1 year	Number of participants who need of adding analgesia medication out of the analgesic pathway used in our center for conventional RATS/VATS
Serious adverse events	Through study completion, an average of 1 year	Complications derived from the operation that altered the pathway
Perioperative complications	Through study completion, an average of 1 year	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
Evaluate Chronic Pain	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montreal, Quebec, Canada