Using ICG to assess blood flow during gastrointestinal surgery
SPY Portable Handheld Imaging (SPY-PHI) System With SPY-QP Software for Quantitative Fluorescence Angiography With IndoCyanine Green for Perfusion Assessment During Surgery
This study is testing if a special dye can help doctors see if there’s enough blood flow during gastrointestinal surgeries to prevent complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 239 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05489757 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of quantitative fluorescence angiography using indocyanine green (ICG) to assess tissue perfusion during gastrointestinal surgeries, specifically esophagogastric and colorectal resections. It aims to enroll 210 patients, where traditional perfusion assessment methods will be compared with ICG analysis to determine the adequacy of blood flow to the surgical site. The surgical strategy will remain unchanged based on the ICG results, and data will be collected for further analysis. This approach seeks to improve the understanding of perfusion dynamics and potentially reduce complications such as anastomotic leakage.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 undergoing esophagogastric or colorectal resections, regardless of whether their condition is malignant or benign.
Not a fit: Patients who have contraindications to ICG, such as known allergies to the dye or severe kidney failure, may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could lead to better surgical outcomes by reducing the risk of complications related to inadequate tissue perfusion.
How similar studies have performed: While the use of ICG for perfusion assessment is gaining traction, this specific approach is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- Lorenzo Cinelli — Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.