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Taking people in RussiaNo phase

Comparing two imaging methods for blood flow in stomach and bowel surgery

Compares a light-based imaging method with ICG dye in stomach or bowel surgery.

Plain-language title generated from the registry record
Registry title: PPG vs. ICG in Gastrointestinal Resections

Key facts

Where
Saint Petersburg, RussiaSee the 2 sites

Where in Russia

  • Department of Faculty Surgery, Saint Petersburg State UniversitySaint Petersburg, RussiaTaking people
  • High-Tech Clinic BeloostrovSaint Petersburg, RussiaNo longer taking part

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Trial details

Who runs it
Saint Petersburg State University, Russia
Trial code
NCT06222645
Record updated
18 November 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Emergency surgery; 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; Inability to comply with the study protocol or follow-up schedule in the investigator's judgment.

ClinicalTrials.gov NCT06222645