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PPG vs. ICG in Gastrointestinal Resections

RecruitingNAAges 18 Years - anyAllSaint Petersburg State University, Russia
NCT06222645 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • ICG fluorescence imaging technology
  • Imaging Photoplethysmography System
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Where

3 sites
Shandong Linglong Yingcheng Hospital
Yantai, China
High-Tech Clinic Beloostrov
Saint Petersburg, Russia
Department of Faculty Surgery, Saint Petersburg State University
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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