Clinical trial NCT04938973: NIF-Guided RAMIE Using ICG Versus OTE Feasibility RCT
Official title: Near-Infrared Fluorescence-Guided Robotic-Assisted Minimally Invasive Esophagectomy Using Indocyanine Green Dye Versus Open Transthoracic Esophagectomy: A Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2021-06-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Canada, the incidence of esophageal cancer has been increasing over time, while surgical standards for esophageal resections have remained unchanged. Currently, the standard of surgical care for this cancer is Open Transthoracic Esophagectomy (OTE), a highly morbid operation that is associated with a complication rate of 60-80%, and a recovery period of many months. While Minimally Invasive Esophagectomy (MIE) has been developed it has not been adopted because it is highly complex, technically demanding, and has a longer operative time than OTE. With the advent of robotic platforms, Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) has recently emerged as a novel minimally invasive alternative to OTE. RAMIE utilizes the DaVinci Xi robotic surgical platform which offers superior dexterity, 3D-vision, and wristed surgical equipment. To date, case reports and small case series have demonstrated the safety of RAMIE, however it has not been performed yet in Canada, and there has been no randomized trial that has compared RAMIE to OTE. This study proposes to build the infrastructure for introducing RAMIE to Canada, while laying the foundations for a future randomized controlled trial which will compare it to OTE.

Detailed description: In Canada, the incidence of esophageal cancer has been increasing over time. The treatment of patients with cancer of the esophagus is multi-modal, with surgery being the cornerstone of most treatment regimens. Operative treatment is usually performed through Open Transthoracic Esophagectomy (OTE), a highly morbid procedure that is associated with a complication rate of 60-80%, and a recovery period of many months. This standard is being challenged by a growing body of evidence demonstrating that a minimally invasive approach can reduce post-operative morbidity and improve quality-of-life, while still offering an adequate oncological outcome. The minimally invasive alternative to OTE is Minimally Invasive Esophagectomy (MIE). Although MIE has been shown to reduce the morbidity associated with esophagectomy, it has not been widely adopted. This failure of adoption is due to the high complexity of MIE; it is an exceedingly difficult operation, is associated with a very steep learning curve, and can take 8-10 hours to complete. As a result, less than 10% of esophageal cancer programs in Canada have adopted MIE, and there remains a need for a minimally invasive alternative to OTE. Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) has recently emerged as a minimally invasive alternative to OTE. RAMIE utilizes the DaVinci Xi robotic surgical platform which offers superior dexterity, 3D-vision, 7-degrees of freedom for range of motion, and near-infrared imaging for detection of blood vessels. As a result, RAMIE has succeeded where MIE has failed, and has been widely taken up in Europe and the United States.

To date, near-infrared fluorescence (NIF)-guided RAMIE using indocyanine green (ICG) dye has not been performed in Canada, and there has been no randomized trial that has compared NIF-guided RAMIE using ICG dye to OTE. In this study, we propose to build the infrastructure for introducing NIF-guided RAMIE using ICG dye to Canada, while laying the foundations for a future randomized controlled trial (RCT) which will compare it to OTE. This study is a Phase I, single center, prospective feasibility randomized controlled trial with two phases: Phase A: Learning Curve of NIF-guided RAMIE using ICG dye; and Phase B: A Randomized Controlled Feasibility Trial. In Phase A, 40 patients will be enrolled, and they will all undergo NIF-guided RAMIE using ICG dye. Evidence shows that a surgeon experienced in MIE requires experience of 40 cases to gain proficiency of RAMIE. In Phase B, 54 patients will be enrolled, and they will be randomized to either NIF-guided RAMIE using ICG dye, or OTE.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Clinical Stage I, II, or III esophageal cancer, who are candidates for surgery after discussion in multidisciplinary tumor board.
* Candidates for minimally invasive surgery as determined by the operating surgeon.

Exclusion Criteria:

* Hypersensitivity or allergy to ICG, sodium iodide, or iodine
* Women who are currently pregnant or are breastfeeding; or women of childbearing potential who are not currently taking adequate birth control
* Clinical Stage IV esophageal cancer.
* Not a candidate for minimally invasive surgery as determined by the operating surgeon.

Primary outcomes:
measure: The feasibility of a large-scale RCT, as measured by the number of patients willing to participate in the study.
timeFrame: 3-Weeks Postoperative
Secondary outcomes:
measure: Safety of the Operation, based on rates of perioperative complications
timeFrame: 12-Weeks Postoperative
measure: Patient-Reported Health-Related Quality of Life - Pain Level
timeFrame: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
measure: Patient-Reported Health-Related Quality of Life - Quality of Life
timeFrame: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
measure: Patient-Reported Health-Related Quality of Life - Reintegration into Normal Living
timeFrame: Baseline, Postoperative Day 1, 3-Weeks Postoperative, 12-Weeks Postoperative
measure: Conversion from RAMIE to OTE
timeFrame: During Surgery
measure: Length of Stay (LOS)
timeFrame: From Date of Admission to Date of Discharge, assessed up to 12-Weeks Postoperative
measure: Length of Operation
timeFrame: During Surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References: