Colorectal Cancer
Conditions
Brief summary
The goal of this clinical trial is to evaluate and compare the clinical utility of Indocyanine Green (ICG) fluorescence angiography and Laser Speckle Contrast Imaging (LSCI) in assessing intraoperative tissue perfusion at the anastomotic site during colorectal resection in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main question\[s\] it aims to answer \[is/are\]: What is the clinical utility of Indocyanine Green (ICG) fluorescence angiography compared to Laser Speckle Contrast Imaging (LSCI) in assessing intraoperative tissue perfusion at the anastomotic site during colorectal resection? Participants will undergo a laparoscopic/robotic (where an extracorporeal anastomosis formed)/open colectomy with ligation of the inferior mesenteric artery and a planned anastomosis of 5cm to 15 cm from the anal verge where both ICG and LSCI modalities will be applied to all subjects.
Detailed description
This is a single-arm, prospective, non-randomized, within-patient crossover study designed to evaluate the effectiveness of Laser Speckle Contrast Imaging (LSCI) using ActivSight™ as an advanced intraoperative visualization tool for assessing tissue perfusion in left-sided colectomies. The standard of care-Indocyanine Green (ICG) fluorescence angiography-will be used concurrently to compare perfusion assessment capabilities between the two imaging modalities. The study will also explore the potential of LSCI in reducing the incidence of anastomotic leak (AL) and related postoperative complications. Participants will undergo left-sided colorectal resection (high or low) with planned anastomosis 5 - 15cm from the anal verge using a circular stapler. The procedure may be performed using either a laparoscopic, open or robotic approach with standard surgical equipment based on the surgeon's standard technique. * High anterior resection is defined as resection and anastomosis above the peritoneal reflection. * Low anterior resection refers to resection and anastomosis below the peritoneal reflection. The specific operative technique, including the method of stapled will be at the discretion of the operating surgeon. The level of colonic transection, formation of an anastomosis, and any defunctioning stoma will be performed in accordance with the surgeon's standard clinical practice
Interventions
DEVICEActivSight™ Intraoperative Imaging System
ActivSight™ Intraoperative Imaging System which consists of an infrared-sensitive monochrome imaging sensor adapter and a customized light source with 1 or more coherent laser sources. In LSCI mode, proprietary algorithms detect perfusion using motion in real time, projecting a false color overlay on the standard white light laparoscopic image. This Food and Drug Administration-approved technology has the capacity for both ICG NIRF and LSCI.
Sponsors
Activ Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled for laparoscopic/robotic (where an extracorporeal anastomosis formed)/open colectomy with ligation of the inferior mesenteric artery and a planned anastomosis of 5cm to 15 cm from the anal verge using a circular stapler only * A negative pregnancy test for women of childbearing potential prior to surgery * Participants who are able and willing to complete required study procedures * Participants who are able and willing to provide a signed and dated ICF
Exclusion criteria
* Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes * Subject who receives hand sewn anastomosis * Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the study procedure * Subject has a previous history of radiation therapy * Subject that has Hinchey 3 and 4 diverticulitis * Subject is a pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| White Light Imaging | during surgery | Determine optimal proximal bowel transection site using white light imaging or naked eye, marking with clip, bovie, pen, etc. |
| ICG Uptake | during surgery | Determine the optimal proximal bowel transection site using at initial uptake of ICG prior to division of bowel and determine diffusion of ICG at 30 seconds, 60 seconds and 90 seconds after initial uptake. |
| LSCI-based Perfusion | during surgery | Determine the optimal proximal bowel transection site using LSCI-based perfusion imaging prior to division of bowel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Perfusion | during surgery | Assess and compare tissue perfusion prior to anastomosis being completed (e.g. anvil has been placed) and post-anastomosis stages using LSCI and ICG. |
| Diversion | during surgery | Decision to divert or not to divert |
| Surgical Decision Making | during surgery | Impact on intraoperative surgical decision-making, including changes in transection site or operative plan. |
| Anastomotic Leak Rate | from surgery to end of follow up period/30 days post surgery | Determine \<30-day postoperative anastomotic leak (AL) rate, associated complications, morbidity, mortality and overall complication rates using the Clavien-Dindo classification system. |
Outcome results
None listed