NCT06222645 PPG vs. ICG in Gastrointestinal Resections
| NCT ID | NCT06222645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saint Petersburg State University, Russia |
| Condition | Anastomosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-11-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06222645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anastomosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06222645 currently recruiting?
Yes, NCT06222645 is actively recruiting participants. Contact the research team at st122986@student.spbu.ru for enrollment information.
Where is the NCT06222645 trial being conducted?
This trial is being conducted at Yantai, China, Saint Petersburg, Russia, Saint Petersburg, Russia.
Who is sponsoring the NCT06222645 clinical trial?
NCT06222645 is sponsored by Saint Petersburg State University, Russia. The trial plans to enroll 200 participants.