Status:
RECRUITING
PPG vs. ICG in Gastrointestinal Resections
Lead Sponsor:
Saint Petersburg State University, Russia
Collaborating Sponsors:
Shandong Linglong Yingcheng Hospital
High-Tech Clinic Beloostrov
Conditions:
Anastomosis
Perfusion
Eligibility:
All Genders
18+ years
Phase:
NA
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 eith...
Detailed Description
This randomized, parallel-group clinical study aims to compare two intraoperative imaging strategies for assessing tissue perfusion in a spectrum of gastrointestinal anastomoses, including both gastro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06222645
Start Date
November 1 2023
End Date
May 31 2026
Last Update
November 18 2025
Active Locations (3)
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1
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, China, 265400
2
High-Tech Clinic Beloostrov
Saint Petersburg, Leningradskaya Oblast', Russia, 197729
3
Department of Faculty Surgery, Saint Petersburg State University
Saint Petersburg, Leningradskaya Oblast', Russia, 199034