- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05489757
Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery (SPY Q-ICG PAS)
SPY Portable Handheld Imaging (SPY-PHI) System With SPY-QP Software for Quantitative Fluorescence Angiography With IndoCyanine Green for Perfusion Assessment During Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Milan, Italy, 20132
- Recruiting
- Lorenzo Cinelli
-
Contact:
- Lorenzo Cinelli, MD
- Phone Number: +39 0226432270
- Email: cinelli.lorenzo@hsr.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The participant is willing and able to give informed consent for participation in the trial
- Male and Female, Age > 18 years
- Patients undergoing left colon, rectal or esophagogastric resections
- Patients with malignant or benign disease
- Minimally invasive or open approach surgery
Exclusion Criteria:
- Absence of esophagogastric or colorectal reconstruction (e.g. Miles procedure)
- Limited sigmoid resection without ligation of the inferior mesenteric artery
- Known allergies, hypersensitivity or intolerance to indocyanine green (ICG) or iodine contrast agents,
- Patients with hyperthyroidism or benign thyroid tumor
- Acute or chronic kidney failure (stage ≥ 3)
- Pregnant or lactating women, or with a positive pregnancy test performed before surgery
- Any clinical condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum intensity of ICG fluorescence
Time Frame: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
|
% (absolute value)
|
One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
|
Time to first ICG fluorescence signal
Time Frame: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
|
seconds
|
One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
|
Time-to-peak
Time Frame: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
|
seconds
|
One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation with postoperative outcomes
Time Frame: From day 0 to day 30 after discharge
|
The rate of anastomotic leakage in patients who underwent colorectal or esophagogastric resections
|
From day 0 to day 30 after discharge
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 154/INT/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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