Actively Recruiting
PPG vs. ICG in Gastrointestinal Resections
Led by Saint Petersburg State University, Russia · Updated on 2025-11-18
200
Participants Needed
3
Research Sites
134 weeks
Total Duration
On this page
Sponsors
S
Saint Petersburg State University, Russia
Lead Sponsor
S
Shandong Linglong Yingcheng Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
PPG vs. ICG in Gastrointestinal Resections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Scheduled for elective gastrointestinal resection with a primary gastro-intestinal or entero-enteric anastomosis
- Able to understand and provide written informed consent
You will not qualify if you...
- Known allergy or hypersensitivity to indocyanine green, iodine, or components of ICG
- Severe liver impairment, such as Child-Pugh Class C
- Pregnancy or breastfeeding
- Emergency surgery
- Unable to comply with the study protocol or follow-up as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, China, 265400
Actively Recruiting
2
High-Tech Clinic Beloostrov
Saint Petersburg, Leningradskaya Oblast', Russia, 197729
Active, Not Recruiting
3
Department of Faculty Surgery, Saint Petersburg State University
Saint Petersburg, Leningradskaya Oblast', Russia, 199034
Actively Recruiting
Research Team
X
Xuan - Qiu, MD
CONTACT
V
Victor A. Kashchenko, MD,PD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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