Clinical trial NCT06735638: Outside the Cage (OTC) Robotic Esophagectomy
Official title: Outside the Cage (OTC) Robotic Esophagectomy , Single Center Phase I Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Minimally invasive esophagectomy (MIE)
Robotic-assisted surgery
Phase I clinical trial
Outside the Cage (OTC) technique
Robotic-assisted thoracic surgery (RATS)
Enhanced recovery after surgery (ERAS)
Non-intercostal approach
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Conversion rate
timeFrame: Through study completion, an average of 1 year
measure: 30-day mortality
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Length of stay
timeFrame: Through study completion, an average of 1 year
measure: Operative time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Postoperative pain
timeFrame: Through study completion, an average of 1 year
measure: Quality of recovery
timeFrame: Through study completion, an average of 1 year
measure: Analgesic complementation requirement
timeFrame: Through study completion, an average of 1 year
measure: Serious adverse events
timeFrame: Through study completion, an average of 1 year
measure: Perioperative complications
timeFrame: Through study completion, an average of 1 year
measure: Evaluate Chronic Pain
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM
state: Quebec
Study officials:
References: