PPG vs. ICG in Gastrointestinal Resections
Recruiting now · Not applicable
Conditions studied: Anastomosis, Perfusion, Postoperative Complications, Gastrointestinal Neoplasms, Gastric Cancer (GC), Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT06222645
- Run by
- Saint Petersburg State University, Russia
- People needed
- 200
- Starts
- 2023-11-01
- Expected to finish
- 2026-05-31
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Shandong Linglong Yingcheng Hospital — Yantai, Shandong, China (enrolling)
- Department of Faculty Surgery, Saint Petersburg State University — Saint Petersburg, Leningradskaya Oblast', Russia (enrolling)
- High-Tech Clinic Beloostrov — Saint Petersburg, Leningradskaya Oblast', Russia
Full record on ClinicalTrials.gov
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