NCT06222645Recruiting
PPG vs. ICG in Gastrointestinal Resections
Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 21 Dec 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Saint Petersburg State University, Russia
- NCT number
- NCT06222645
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Nov 2023 to the primary completion date, 30 Apr 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery.
Other illness
- 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).
Other
- Pregnancy or lactation.
- Inability to comply with the study protocol or follow-up schedule in the investigator's judgment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Linglong Yingcheng Hospital Coordinator of this site? Confirm its status | Yantai | China | Recruiting |
| High-Tech Clinic Beloostrov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Active, not recruiting |
| Department of Faculty Surgery, Saint Petersburg State University Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.