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PPG vs. ICG in Gastrointestinal Resections
Sponsor: Saint Petersburg State University, Russia
Summary
This randomized controlled trial compares a novel optical technique against the standard of care for assessing tissue perfusion in gastrointestinal surgery. Participants are randomized to receive either intraoperative imaging photoplethysmography (iPPG) or indocyanine green (ICG) fluorescence imaging. In the ICG group, the fluorescence data are comprehensively analyzed in two distinct ways: (1) Qualitative Assessment: real-time visual interpretation of the angiogram flow by the operating surgeon; and (2) Quantitative Assessment: software-based analysis of fluorescence kinetics (e.g., time-to-peak, maximum intensity) to generate objective perfusion parameters. The study aims to determine the agreement between the iPPG-based evaluations and both the qualitative and quantitative dimensions of the ICG standard.
Official title: Comparison Between Fluorescenceimaging With Photoplethysmography (PPG) and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-11-01
Completion Date
2026-05-31
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
ICG fluorescence imaging technology
This intervention involves the intravenous injection of the fluorescent contrast agent Indocyanine Green (ICG), followed by imaging with a near-infrared fluorescence camera system. Upon illumination with near-infrared light, ICG in the bloodstream fluoresces, allowing for real-time visualization of blood flow and tissue perfusion (qualitative assessment). Additionally, the fluorescence intensity over time can be recorded for subsequent quantitative analysis of perfusion kinetics.
Imaging Photoplethysmography System
Imaging photoplethysmography is a non-contact, camera-based optical imaging technique. This investigational system operates by detecting subtle modulations in optical signals associated with pulsatile blood volume changes in microvascular tissue. It utilizes a conventional video camera to capture these signals and generates real-time tissue perfusion maps without the need for any exogenous contrast agents. The system is designed to provide intraoperative guidance for assessing tissue viability during gastrointestinal anastomoses.
Locations (3)
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, China
High-Tech Clinic Beloostrov
Saint Petersburg, Leningradskaya Oblast', Russia
Department of Faculty Surgery, Saint Petersburg State University
Saint Petersburg, Leningradskaya Oblast', Russia