Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Incidence of Anastomotic Leak
研究概览
简要总结
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.
详细描述
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-intestinal and entero-enteric reconstructions. The primary objective is to evaluate the diagnostic performance and clinical utility of a novel, non-contact optical technique-imaging photoplethysmography (iPPG)-against the current clinical standard, indocyanine green (ICG) fluorescence imaging.
Eligible and consented patients will be randomly assigned to one of two arms. The iPPG Arm will undergo perfusion evaluation solely using the investigational iPPG system. This method leverages a conventional video camera to detect pulsatile blood volume changes in microvascular tissue, offering a non-invasive, contrast-agent-free approach to perfusion assessment. The ICG Arm will be assessed using the standard fluorescence imaging protocol. A key feature of the study design is the pre-specified, comprehensive analysis within the ICG arm, which will incorporate both a qualitative assessment (the surgeon's real-time visual interpretation of the angiogram) and a quantitative analysis (computer-based calculation of fluorescence kinetics parameters, such as time-to-peak and inflow slope).
The study is designed to provide a head-to-head comparison of the two guiding strategies. Outcomes from the iPPG-guided arm will be systematically benchmarked against those from the ICG-guided arm. Furthermore, the internal comparison between qualitative and quantitative assessments within the ICG arm will yield valuable insights into the optimal methodology for interpreting perfusion data in clinical practice. This design allows for the evaluation of iPPG not only as a potential alternative to ICG but also for the refinement of the standard itself.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
For the purpose of objective quantitative analysis, all recorded imaging sequences (iPPG and ICG) will be anonymized and randomized. A dedicated data analyst, who is masked to the group identity (iPPG vs. ICG) and clinical outcomes of each sequence, will then process this dataset to extract the perfusion parameters (e.g., iPPG waveform amplitude, ICG time-to-peak). The surgical team remains unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Indocyanine green (ICG) imaging system
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.
干预措施: ICG fluorescence imaging technology (Drug)
Indocyanine green (ICG) imaging system
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.
干预措施: Imaging Photoplethysmography System (Device)
imaging photoplethysmography (iPPG)
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.
干预措施: ICG fluorescence imaging technology (Drug)
imaging photoplethysmography (iPPG)
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.
干预措施: Imaging Photoplethysmography System (Device)
结局指标
主要结局
Incidence of Anastomotic Leak
时间窗: 30 days postoperatively
Comparison of the rate of clinically significant anastomotic leak between the iPPG-guided group and the ICG-guided group. Anastomotic leak is defined as a full-thickness defect requiring radiological, endoscopic, or surgical intervention, as confirmed by an independent clinical events committee within 30 days postoperatively.
Incidence of Anastomotic Leak: Qualitative vs Quantitative ICG Assessment
时间窗: 30 days postoperatively
Comparison of the rate of clinically significant anastomotic leak between patients whose intraoperative assessment was based on qualitative ICG imaging (surgeon's visual interpretation) versus those assessed with quantitative ICG parameters (software-based kinetic analysis). Anastomotic leak is defined as a full-thickness gastrointestinal defect requiring postoperative radiological, endoscopic, or surgical intervention, as confirmed by an independent adjudication committee. This analysis will be performed specifically within the cohort of patients randomized to the ICG arm.
次要结局
- Diagnostic Performance for Predicting Anastomotic Leak(he perfusion assessment is performed intraoperatively. The outcome (anastomotic leak) is assessed at 30 days postoperatively.)
- Rate of Anastomotic Revision Based on Perfusion Assessment(Intraoperative (Measured immediately following the perfusion assessment of the initially constructed anastomosis))
- Overall Postoperative Complication Rate(30 days postoperatively)
- Rate of Re-intervention(30 days postoperatively)
研究者
Xuan Qiu
Principal Investigator
Saint Petersburg State University, Russia