Fluorescent Evaluation of Colorectal Anastamoses
Condition: Rectal Neoplasms; Colon Neoplasms; Diverticulitis
MeSH terms: Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Diverticulitis
Study type: Interventional

Summary: 
      Bowel removal is indicated for various types of colon and rectal disease, including colon
      cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others.

      Following removal of the diseased segment of bowel your surgeon will reconnect the two
      healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an
      extremely dangerous situation.

      The cause of leakage has many causes and is not well understood, but appears to be at least
      in part due to not having enough blood going to the bowel. There is currently no way to
      evaluate the blood supply to the bowel.

      The purpose of this study is to utilize a special camera to evaluate the blood supply of the
      bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing
      the occurrence of leaks
    

Detailed description: 
      The purpose of this study is to evaluate whether systemically injected ICG, when fluorescing
      in response to NIR illumination, can assist with the assessment of perfusion at a bowel
      anastomotic site. This finding may assist surgeons to minimize the occurrence of leaks at the
      anastomotic site following this surgical procedure. The present study is a preliminary
      investigation to determine if this imaging modality will yield information regarding
      perfusion that is likely to be clinically relevant and so determine if a larger, multi center
      trial that correlates perfusion to clinical outcome is warranted. The results of the present
      study will also assist in the design of a larger scale study. It is expected that a
      successful outcome to such a trial will result in less morbidity following laparoscopic
      colectomy.

      Laparoscopic bowel surgery is indicated for colon cancer, rectal cancer, diverticulitis,
      inflammatory bowel disease (including ulcerative colitis or Crohn's disease) and infarcted
      bowel. Prophylactic colectomy is also indicated for certain forms of polyposis to mitigate
      the risk of progression to colon cancer. The portion of colon resected during a colectomy is
      dependent upon the nature of the disease and its location and extent. Traditionally,
      colectomy has been performed by means of laparotomy, a standard abdominal incision. In recent
      years, beginning in the early 1990s, there has been increasing interest in, and utilization
      of, minimally invasive techniques for surgical procedures involving the colon and rectum.
      Laparoscopic surgery involves the introduction of surgical instruments through a number
      (usually 2-3) of small incisions measuring about 10-12 mm each with visual guidance being
      provided by means of a camera attached to an endoscope introduced through a similarly small
      access port. Laparoscopic techniques offer numerous benefits including a decrease in
      postoperative pain, some improvement in time to tolerance of food and return of bowel
      function, shorter hospital stay and more rapid return to normal activity.

      Irrespective of the type of procedure performed (open or laparoscopic), anastomotic leakage
      following colorectal resection and primary anastomosis is a major clinical problem. The
      incidence of intraperitoneal anastomotic leaks reported in the literature may be as high as
      30%. Anastomotic leaks leads to increased length of hospital stay, and may progress to
      abscess formation, sepsis, multi organ failure and even death.

      The cause of anastomotic leakage is multifactorial with the following factors appearing to
      impact upon leakage; adequacy of blood flow to the anastomosis, contamination, the presence
      of a pelvic drain, anastomotic tension, anastomotic technique and the distance from the anal
      verge . The present study will investigate the first factor listed above, adequacy of blood
      flow to the anastomosis. At present there is no reliable and easy-to-perform modality that
      can be used to assess adequacy of perfusion at the anastomosis during colorectal procedures.
      This study will investigate the potential for the SPY scope to fill this clinical need.

      The SPY® Intraoperative Imaging System is cleared for use in Canada, Japan, Europe and the
      US. SPY was originally developed for applications in cardiac surgery and allows cardiac
      surgeons to visually assess bypass graft quality in real-time while the patient is still in
      the operating room. Subsequently, SPY has received clearance from the FDA for use in plastic
      and reconstructive surgery and in solid organ transplant.

      The SPY Intraoperative Imaging System was originally developed for open surgical procedures
      using ICG, which is an approved drug. ICG is a fluorescent compound, which can be
      administered intravenously or intra-arterially. The dye absorbs light in the near infrared
      (NIR) region at 806 nm, and emits light at a slightly longer wavelength, 830 nm. When
      injected intravenously, ICG rapidly and extensively binds to plasma proteins and is confined
      to the intravascular compartment with minimal leakage into the interstitium under normal
      conditions. This property makes it an ideal agent for the acquisition of high quality images
      of the vasculature. Intraoperative images are acquired during the first pass of a bolus of
      ICG through the area of interest. The SPY System has been the subject of numerous peer
      reviewed publications demonstrating its safety and efficacy .

      SPY scope, the endoscopic version of SPY, is an endoscopic visible (VIS) NIR imaging system
      consisting of:

        -  An endoscopic light source that provides illumination for visible light imaging and NIR
           fluorescence excitation to the endoscope via a flexible light guide

        -  Rigid endoscopes optimized for illuminating the field of view and transmitting images in
           the visible and NIR spectrum, and

        -  A high definition (HD) endoscopic camera system connected to the endoscope eyepiece and
           acquiring high resolution visible and NIR fluorescence images The ICG (25 mg per vial)
           will be reconstituted according to the manufacturer's instructions using the entire
           contents (10 ml) of the sterile diluent supplied, yielding a 2.5 mg/ml solution of ICG
           or using half of the diluent supplied (5 ml) yielding a 5 mg/ml solution.
    

Intervention name(s): Indocyanine Green; The SPY® Intraoperative Imaging System
Intervention type(s): Device; Device
Intervention description(s): 1ml of intravenous ICG and imaging transanally using the Spyscope system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Rectal Cancer; Colon Cancer; Diverticulitis; Anastamosis; colectomy; low anterior resection