Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05489757 |
| Other study ID # |
154/INT/2021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 16, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
IRCCS San Raffaele |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The accurate assessment of intraoperative tissue perfusion is essential in any branch of
surgery. Anastomotic leakage (AL) is one of the most feared complications following
gastrointestinal surgery, with potentially threatening consequences resulting in worsened
short- and long-term outcomes. Consistently, a recent meta-analysis showed a correlation
between AL and shorter disease-free survival in colorectal surgery. Despite its
multifactorial origin, AL is highly related to inadequate visceral perfusion. Traditionally,
perfusion assessment and subsequent anastomotic viability have been evaluated by surgeons
using intraoperative indicators, such as color, pulsation of vessels, presence of peristalsis
and bleeding from the resection lines. However, these clinical parameters are not able to
reliably assess the real visceral perfusion and their evaluation is limited in minimally
invasive surgery. Hence, the growing interest for innovative techniques able to properly
assess tissue perfusion. Among these, the fluorescence angiography (FA) with indocyanine
green (ICG) has become increasingly popular during the last decade, although its approval for
biomedical purposes by the Food and Drug Administration (FDA) dates back to 1956. ICG is an
amphiphilic, non-toxic, tricarbocyanine iodide dye that can be safely injected intravenously
and is exclusively eliminated by the liver, without any absorption. Thanks to its fluorescent
properties, it allows the real-time visualization of tissue vascularization. FA with ICG has
shown promising results for the evaluation of perfusion in numerous surgical procedures, thus
leading to modifications of the surgical strategy and consequently to a decrease in the rates
of AL. On the other hand, ICG interpretation is subjective, based on the evaluation of
fluorescence performed by the operating surgeon. These results lack into a high
inter-observer variability and affect the possibility to obtain objective, reproducible and
reliable tissue perfusion assessments.
Quantitative fluorescence angiography with ICG (Q-ICG) could overcome these limitations. In
Q-ICG the fluorescence signal is elaborated by a new computer quantification algorithm and
translated into a fluorescence-time curve (FTC), from which several Q-ICG parameters and
values can be extracted. Given the power of ICG in reflecting the perfusion of examined
tissues, a new quantification algorithm has the potential to turn the subjective parameters
derived from surgeon's perspective into objective numeric values.
The primary aim of this study is to evaluate which Q-ICG values provided by a new
quantification algorithm correspond to subjective perfusion parameters usually evaluated by
the surgeon in patients undergoing left colon, rectal or esophagogastric resections.
The secondary aim is to evaluate possible correlations between Q-ICG values provided by the
quantification algorithm and perioperative outcomes.
Description:
The study is designed as a prospective, observational, monocentric, cohort study on
algorithm. At our Institution ICG is already used routinely to assess visceral perfusion
during gastrointestinal operations. We plan to enroll 70 patients for esophagogastric
resections and 140 patients for colorectal resections. Firstly, the adequacy of colon or
gastric perfusion will be assessed by the surgical team in the traditional way. Color,
pulsatile flow of vessels (right gastroepiploic arcade for the gastric conduit, marginal
artery for the colon), presence of peristalsis and bleeding from the colic resection lines
will be considered as parameters of perfusion. Then, ICG will be injected, Q-ICG analysis
will be performed in all the patients by using a new quantification algorithm and data will
be recorded and reported in a specific Database. The surgical strategy will not be modified
based on Q-ICG results.
