Comparison Between Fluorescence Imaging With Photoplethysmography (PPG) and Indocyanine Green (ICG) for Tissue Perfusion in Gastrointestinal Resections

What this Trial Is About

Researchers are evaluating two intraoperative imaging methods to assess tissue perfusion during gastrointestinal surgeries involving anastomoses. This randomized controlled trial compares a new non-contact optical technique called imaging photoplethysmography (iPPG) to the current standard, indocyanine green (ICG) fluorescence imaging. The aim is to determine how well the iPPG evaluations agree with both the visual and software-based analyses used in the ICG method, potentially refining perfusion assessment in clinical practice. Participants are randomly assigned to one of two groups. One group receives tissue perfusion assessment with the standard ICG fluorescence imaging, which requires an intravenous injection of the fluorescent dye ICG and involves both real-time visual interpretation by the surgeon and quantitative computer analysis of fluorescence data. The other group is assessed using the investigational iPPG system, which uses a conventional video camera to detect blood volume changes without any contrast agents, providing real-time perfusion maps to guide surgical decisions. During the study, participants undergo intraoperative perfusion evaluation based on their assigned method. Researchers measure outcomes including the incidence of anastomotic leaks within 30 days after surgery, comparing qualitative and quantitative assessments in the ICG group and benchmarking iPPG results against these. Additional outcomes include rates of anastomotic revision, postoperative complications, and re-interventions. The total follow-up period for measuring these outcomes is 30 days postoperatively, allowing for comprehensive evaluation of each imaging strategy's clinical utility.

PPG vs. ICG in Gastrointestinal Resections