Comparing two imaging techniques for gastrointestinal surgeries
Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
NA · Saint Petersburg State University, Russia · NCT06222645
This study is testing two different imaging methods to see which one better helps doctors check blood flow in patients who have had gastrointestinal surgeries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Petersburg State University, Russia (other) |
| Locations | 3 sites (Yantai, Shandong and 2 other locations) |
| Trial ID | NCT06222645 on ClinicalTrials.gov |
What this trial studies
This study examines gastrointestinal anastomoses using two imaging techniques: Imaging Photoplethysmography (iPPG) and Standard Routine Indocyanine Green (ICG) Imaging. The iPPG is a non-invasive method that detects blood pulsation in vessels using a conventional video camera, while ICG is a fluorescence imaging technique used to measure tissue perfusion. Both methods will be applied to patients with gastrointestinal anastomoses, and their perfusion data will be compared to evaluate the effectiveness of iPPG against the standard ICG method.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing gastrointestinal anastomoses who can provide informed consent.
Not a fit: Patients who are unable to consent or have an allergy to indocyanine green dye will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and non-invasive method for assessing tissue perfusion during gastrointestinal surgeries.
How similar studies have performed: While the use of ICG is well-established, the application of iPPG in this context is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Yantai, Shandong and 2 other locations
- Shandong Linglong Yingcheng Hospital — Yantai, Shandong, China (RECRUITING)
- High-Tech Clinic Beloostrov — Saint Petersburg, Leningradskaya Oblast', Russia (ACTIVE_NOT_RECRUITING)
- Department of Faculty Surgery, Saint Petersburg State University — Saint Petersburg, Leningradskaya Oblast', Russia (RECRUITING)
Study contacts
- Study coordinator: Xuan - Qiu, MD
- Email: st122986@student.spbu.ru
- Phone: 79643411524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anastomosis, Perfusion, Postoperative Complications, Gastrointestinal Neoplasms, Gastric Cancer, Colorectal Cancer, Photoplethysmography, Indocyanine Green