Efficiency, safety and feasibility of PerfusiX-Imaging for Gastro-Intestinal tissue perfusion assessment in humans.

Any gastrointestinal resection causes inevitable vascular damage, which is not
always evident during an intraoperative clinical assessment of local intestinal
perfusion. However, if left unaltered, impaired perfusion can lead to
anastomotic healing complications such as anastomotic leakage (AL). Owing to
its detrimental effect on both short and long-term outcomes (e.g., increased
30-day mortality risk, worsened oncological prognosis), AL is also one of the
most severe possible complications of gastrointestinal tract surgery. A
significant percentage of patients undergoing restorative intestinal surgery
develop AL, leading to both considerable morbidity and mortality. Impaired
perfusion is one of the key factors implicated in anastomotic failure. Ensuring
adequate perfusion is an important part of a multidimensional approach to
gradually improving the overall outcome in restorative intestinal surgery.
Thus, there is a need for an objective measure of perfusion suitable for
laparoscopic use.
Today, the most commonly used method for the assessment of tissue perfusion for
the gastrointestinal tract (and in general) is the mere simple inspection using
the surgical eye. However, it is hard to objectify and the judgement is heavily
dependent on the surgeons* experience. More recently, ICG-fluorescence imaging
was introduced in the surgical theater for the visualization of
gastrointestinal blood flow. Unfortunately, this approach is suboptimal in
effectiveness (Non-flowing blood containing ICG gives the same signal as
flowing blood containing ICG (i.e., lacks objectivity and specificity for
flowing blood)) and it is cumbersome to efficient workflow (need for contrast
agent, reagent preparation and injection, potential adverse allergic
reactions). The use of a dye limits the user in perfusion visualization
duration, repetitiveness and introduces a lack-time between the need for
perfusion visualization and the actual visualization.
PerfusiX-Imaging is a dye-free method that could simplify, and thus speed up,
objective intraoperative perfusion assessment. The device is added to the
laparoscopic trolley and thereby is able to upgrade any laparoscopic video
system with perfusion imaging possibilities. In comparison to the current
clinical practice of gastrointestinal tissue visualization, based on the mere
visual inspection by human eye or the cumbersome ICG-based systems, our
hypothesis is that PerfusiX-Imaging delivers safe, precise, objective and
real-time visualization of blood flow and tissue perfusion intraoperatively
during minimally invasive surgery with the following benefits:
1) Quantitative images: PerfusiX-Imaging is based on the LSCI technology and
thus provides objective information related to tissue perfusion
2) No contrast agent: PerfusiX-Imaging does not require the use of a contrast
agent. This means the surgeon can visualize perfusion at any time during
surgery, for as long as required and with as many repetitive measurements are
deemed necessary.
3) Real-time: PerfusiX-Imaging will visualize the tissue perfusion in
real-time. This allows the surgeon to manipulate tissue (e.g., clamping blood
vessels) and visualize the effect on tissue perfusion directly. (i.e., this is
not possible using current technologies)
4) Lower patient risk: The risk of adverse events related to the injection of
contrast agents is eliminated associated with comparable imaging systems, as
PerfusiX-Imaging does not require a contrast agent
5) Usability: PerfusiX-Imaging will visualize tissue perfusion in real-time
without the interruption of the workflow as the visualization is ready at the
press of a button.

The study objective is to evaluate the efficiency of PerfusiX-Imaging compared
to the current state of the art for perfusion measurements; indocyanine green
fluorescence imaging. Also, feasibility and safety of PerfusiX-Imaging for
perfusion visualization of gastrointestinal anastomoses. The safety will be
determined through clinical assessments and evaluation of any adverse event.
The feasibility will be determined through the technically successful
completion of the perfusion visualization. Patients will be in a follow-up to
30 days postoperatively monitored for the clinical outcome.

The current study is a single-center, randomized, intervention study in the
Medical Center Leeuwarden.

All patients will undergo the standard-of-care program which includes perfusion
assessment by the surgical eye. In addition to this standard-of-care,
2D-perfusion maps will be generated of the gastrointestinal perfusion before
the creation of the gastrointestinal anastomoses using PerfusiX-Imaging
perfusion mode in combination with a proprietary third-party surgical
laparoscope or using ICG-fluorescence imaging depending on group allotment.

Burden
The surgical procedure will be extended by a short amount of time (<5 min).

Risks
PerfusiX-Imaging poses non-significant low safety concerns based on the fact
that the device has no patient contact with a very low laser output.

Benefit
The proposed trial poses minimal risk and maximum potential benefits for
perfusion imaging of the gastrointestinal tract thereby aiding in better
substantiated clinical decision making.