PPG vs. ICG in Gastrointestinal Resections
Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
1 other identifier
interventional
200
2 countries
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedNovember 18, 2025
November 1, 2025
2.5 years
December 21, 2023
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Anastomotic Leak
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.
30 days postoperatively
Incidence of Anastomotic Leak: Qualitative vs Quantitative ICG Assessment
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.
30 days postoperatively
Secondary Outcomes (4)
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
Other Outcomes (2)
Surgeon Confidence Score
Intraoperative (Assessed immediately after perfusion evaluation and before fascial closure)
Time from Imaging to Decision
Intraoperative (Measured for each anastomosis assessment event)
Study Arms (2)
Indocyanine green (ICG) imaging system
ACTIVE COMPARATORParticipants 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.
imaging photoplethysmography (iPPG)
EXPERIMENTALParticipants 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.
Interventions
This intervention involves the intravenous injection of the fluorescent contrast agent Indocyanine Green (ICG), followed by imaging with a near-infrared fluorescence camera system. Upon illumination with near-infrared light, ICG in the bloodstream fluoresces, allowing for real-time visualization of blood flow and tissue perfusion (qualitative assessment). Additionally, the fluorescence intensity over time can be recorded for subsequent quantitative analysis of perfusion kinetics.
Imaging photoplethysmography is a non-contact, camera-based optical imaging technique. This investigational system operates by detecting subtle modulations in optical signals associated with pulsatile blood volume changes in microvascular tissue. It utilizes a conventional video camera to capture these signals and generates real-time tissue perfusion maps without the need for any exogenous contrast agents. The system is designed to provide intraoperative guidance for assessing tissue viability during gastrointestinal anastomoses.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Saint Petersburg State University, Russialead
- Shandong Linglong Yingcheng Hospitalcollaborator
- High-Tech Clinic Beloostrovcollaborator
Study Sites (3)
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, 265400, China
High-Tech Clinic Beloostrov
Saint Petersburg, Leningradskaya Oblast', 197729, Russia
Department of Faculty Surgery, Saint Petersburg State University
Saint Petersburg, Leningradskaya Oblast', 199034, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2023
First Posted
January 25, 2024
Study Start
November 1, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR