Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery

Launched by IRCCS SAN RAFFAELE · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new method called quantitative fluorescence angiography using indocyanine green (Q-ICG) to better assess blood flow to tissues during surgery for conditions affecting the esophagus and rectum. This is important because poor blood flow can lead to complications like leaks at the surgical site, which can make recovery difficult. The trial aims to compare the new Q-ICG method, which uses a computer to provide clear, numerical data about blood flow, with traditional methods that rely on the surgeon's observations, which can be subjective and vary between doctors.

To participate in the trial, individuals must be at least 18 years old and undergoing specific types of surgeries on the left colon, rectum, or esophagus, whether for cancer or other conditions. They must also be able to give informed consent. Participants will have the opportunity to help researchers understand if the new Q-ICG method can improve surgical outcomes by providing more accurate assessments of blood flow. It’s important to note that certain individuals, such as those with specific allergies or kidney issues, may not be eligible. Overall, this trial could lead to safer surgeries and better recovery for patients.

Gender

ALL

Eligibility 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