3-Dimensional Virtual Reality Modelling With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping: All patients in Phase I and those randomized to Intervention in Phase II will have preoperative 3D VR reconstructions of their pulmonary anatomy with the target lesion created using the Elucis platform. Segment identification and confidence rating will be collected before and after visualizing the 3D VR reconstruction. Intraoperatively, the surgeon will use this 3D VR model as a guide to determine which inflow and outflow vessels to the involved segment need to be removed. After vascular ligation, a 8mL bolus of ICG solution will be injected into a peripheral vein catheter by anesthesia. The surgeon will mark out the segmental plane based on the fluorescence pattern seen on the infrared mode of the robotic camera. The surgeon will then perform the pulmonary resection and the resected non-fluorescent lung segment will be extracted from the body cavity. Study patients will receive routine postoperative care as non-study patients and will be followed until the 3-4-week mark.

3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping: The patients that are randomized to Control in Phase II will undergo the same intervention as above, but instead of using Elucis for 3D VR reconstructions, Synapse 3D will be used for 3D reconstructions.

Study summary

With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D virtual reality (VR) anatomical planning (Elucis) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Elucis-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.

If successful, this project will establish a novel operation that has the potential of increasing the rates of success for segmental resection. This will allow for further research that will externally validate this technique and ensure that it is reproducible in other centres by other surgeons. As segmental resection is the new standard of care for surgical management of early-stage NSCLC, and because lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.

Equally importantly, the investigators believe that this method will enable them to develop a new way of teaching lung resections, in a manner that is more effective for learners. Further research on the role of VR in teaching lung cancer surgery will very likely be a downstream effect of developing this surgical method.

Eligibility

Primary outcome measure(s)

• Phase I: Feasibility of the operation — Through study completion, an average of 2 years
  Based on the proportion of completed minimally invasive segmental resections. A rate of 60%, similar to the established current standard, will be considered adequate.
• Phase I: Safety of the operation — 30-days from date of surgery
  Based on rates of perioperative complications within 30-days of surgery, as defined by the Ottawa Thoracic Morbidity \& Mortality (TMNM) System.
• Phase I: Surgeon's learning curve — Through study completion, an average of 2 years
  Evaluated using CUSUM analysis of operative time and successful segmentectomy completion rate over time.
• Phase II: Rate of conversion to robotic lobectomy in each arm — Through study completion, an average of 2 years
  Evaluated based on the proportion of minimally invasive segmental resections converted to robotic lobectomy in each arm.

Trial sites (1)

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