RecruitingNot ApplicableNCT06222645

PPG vs. ICG in Gastrointestinal Resections

Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections

Sponsor

Saint Petersburg State University, Russia

Enrollment

200 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer (GC)Postoperative Complications Gastrointestinal Neoplasms Anastomosis Perfusion

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two imaging methods — PPG (photoplethysmography) and ICG (indocyanine green fluorescence) — used during bowel surgery to check if the blood supply to the newly joined sections of bowel is adequate. Good blood supply at the join (anastomosis) reduces the risk of leakage after surgery. **You may be eligible if...** - You are 18 years old or older - You are scheduled for a planned (non-emergency) surgical procedure to remove a portion of the digestive tract and reconnect the ends - You are able to understand and sign the informed consent form **You may NOT be eligible if...** - You have a known allergy to ICG dye, iodine, or any related substance - You have severe liver disease - You are pregnant or breastfeeding - You require emergency surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGICG 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.

DEVICEImaging 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.