Clinical trial · Interventional
PPG vs. ICG in Gastrointestinal Resections
Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomosis | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Perfusion | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG fluorescence imaging technology | Drug | — | UNRESOLVED |
| Imaging Photoplethysmography System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Indocyanine green (ICG) imaging system
- description
- Participants in this arm undergo intraoperative tissue perfusion assessment guided by the standard Indocyanine Green (ICG) fluorescence imaging. This involves intravenous ICG injection. Perfusion is evaluated comprehensively through both qualitative (surgeon's visual interpretation) and quantitative (computer-based analysis of fluorescence kinetics, e.g., time-to-peak) methods. This arm represents the current standard of care.
- interventionNames
- Drug: ICG fluorescence imaging technology
- Device: Imaging Photoplethysmography System
- type
- EXPERIMENTAL
- label
- imaging photoplethysmography (iPPG)
- description
- Participants in this arm undergo intraoperative tissue perfusion assessment guided by the investigational Imaging Photoplethysmography (iPPG) system. This non-contact, camera-based technique detects microvascular blood volume changes without requiring exogenous contrast agents. The surgical team uses the real-time iPPG perfusion maps to evaluate anastomotic viability and guide surgical decisions.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available