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

Inclusion Criteria3

Adult patients (age ≥ 18 years).
Scheduled to undergo an elective gastrointestinal resection requiring a primary gastro-intestinal or entero-enteric anastomosis.
Able to understand and provide written informed consent.

Exclusion Criteria5

Known hypersensitivity or allergy to indocyanine green (ICG), iodine, or any component of the ICG formulation.
Severe hepatic impairment (e.g., Child-Pugh Class C).
Pregnancy or lactation.
Emergency surgery.
Inability to comply with the study protocol or follow-up schedule in the investigator's judgment.

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.