PPG vs. ICG in Gastrointestinal Resections

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.

NCT Number	NCT06222645
Lead Sponsor	Saint Petersburg State University, Russia Collaborators: Shandong Linglong Yingcheng Hospital, High-Tech Clinic Beloostrov
Conditions	Anastomosis, Perfusion, Postoperative Complications, Gastrointestinal Neoplasms, Gastric Cancer (GC), Colorectal Cancer
Enrollment	200 participants
Start Date	2023-11-01
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-18