PPG vs. ICG in Gastrointestinal Resections
Recruiting · NCT06222645 · Interventional (participants receive a specific treatment) · Lead sponsor: Saint Petersburg State University, Russia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
3 locations listed.
- High-Tech Clinic Beloostrov - Saint Petersburg, Leningradskaya Oblast', Russia
- Department of Faculty Surgery, Saint Petersburg State University - Saint Petersburg, Leningradskaya Oblast', Russia
- Shandong Linglong Yingcheng Hospital - Yantai, Shandong, China