AnastomosisNCT06222645
PPG vs. ICG in Gastrointestinal Resections
A study testing ICG fluorescence imaging technology and Imaging Photoplethysmography System in people with Anastomosis and Perfusion, run by Saint Petersburg State University, Russia at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomosis, Perfusion, Postoperative Complications
- What is being tested?
- ICG fluorescence imaging technology and Imaging Photoplethysmography System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Russia2 sites, 1 recruiting
- Active, not recruiting
High-Tech Clinic Beloostrov
Saint Petersburg, Leningradskaya Oblast', 197729
- Recruiting
Department of Faculty Surgery, Saint Petersburg State University
Saint Petersburg, Leningradskaya Oblast', 199034
Xuan Qiuxuan, MD, 79643511524, qiuxuan100@163.com
China1 site, 1 recruiting
- Recruiting
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, 265400
Xuan Qiu, MD, 8618354280081, qiuxuan100@163.com
About this study
Official title: Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion 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.
Read the 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-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.
- Conditions
- Anastomosis, Perfusion, Postoperative Complications, Gastrointestinal Neoplasms, Gastric Cancer (GC), Colorectal Cancer
- Being tested
- ICG fluorescence imaging technology, Imaging Photoplethysmography System
- Keywords
- Photoplethysmography, Indocyanine Green, Fluorescence Imaging, Anastomotic Leak, Gastrointestinal Surgery, Tissue Perfusion, Intraoperative Monitoring
- Medical subject headings
- Postoperative Complications, Gastrointestinal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG fluorescence imaging technologyDrug
Also called ICG Imaging, ICG Angiography, Near-Infrared Fluorescence Imaging
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 SystemDevice
Also called iPPG, PPG Imaging
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.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine green (ICG) imaging system | Active comparator | 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. Receives: Drug: ICG fluorescence imaging technology; Device: Imaging Photoplethysmography System |
| imaging photoplethysmography (iPPG) | Experimental | 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. Receives: Drug: ICG fluorescence imaging technology; Device: Imaging Photoplethysmography System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days postoperatively
Secondary outcomes (4)
Diagnostic Performance for Predicting Anastomotic Leak
To evaluate and compare the diagnostic accuracy of the intraoperative iPPG assessment versus the standard ICG assessment (including both qualitative and quantitative methods) in predicting the occurrence of a postoperative anastomotic leak. The perfusion assessment during surgery will be dichotomized as 'inadequate' or 'adequate'. Diagnostic performance metrics including Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and the Area Under the Receiver Operating Characteristic Curve (AUC-ROC) will be calculated for each modality against the clinical outcome of anastomotic leak.
Measured: he perfusion assessment is performed intraoperatively. The outcome (anastomotic leak) is assessed at 30 days postoperatively.
Rate of Anastomotic Revision Based on Perfusion Assessment
To quantify and compare the immediate impact of perfusion assessment on surgical decision-making by recording the frequency at which the operating surgeon decides to revise the anastomosis (i.e., resect and re-anastomose the bowel segment) based solely on the intraoperative findings of either iPPG or ICG imaging. The revision rate will be calculated as the proportion of patients in each arm (iPPG and ICG) for whom the anastomosis was revised due to perceived inadequate perfusion.
Measured: Intraoperative (Measured immediately following the perfusion assessment of the initially constructed anastomosis)
Overall Postoperative Complication Rate
To comprehensively evaluate and compare the overall postoperative morbidity between the iPPG-guided group and the ICG-guided group. All complications occurring within 30 days after surgery will be recorded and graded according to the Clavien-Dindo classification system. This standardized system categorizes complications based on the level of intervention required for management, ranging from Grade I (any deviation from the normal postoperative course not requiring pharmacological/surgical intervention) to Grade V (death). The comparison will focus on the incidence of complications of Grade II and above.
Measured: 30 days postoperatively
Rate of Re-intervention
To compare the incidence of unplanned, procedure-related re-interventions between the iPPG-guided and ICG-guided groups. A re-intervention is defined as any subsequent surgical, endoscopic, or radiology-guided invasive procedure required to manage a complication related to the initial gastrointestinal resection and anastomosis (e.g., control of bleeding, drainage of an intra-abdominal collection, or repair of an anastomotic leak). Planned, staged procedures are excluded. The rate is calculated as the proportion of patients in each group undergoing at least one such re-intervention.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a randomized, parallel-group design. Participants are randomly allocated to one of two distinct intraoperative assessment arms: 1. iPPG Arm: Perfusion assessment is guided solely by the investigational Imaging Photoplethysmography (iPPG) system. 2. ICG Arm: Perfusion assessment is guided by the standard Indocyanine Green (ICG) fluorescence imaging. The evaluation within this arm is comprehensive, encompassing both qualitative assessment (real-time visual interpretation of the angiogram by the surgeon) and quantitative analysis (software-based kinetics of the fluorescence intensity). The primary comparative analysis will benchmark the outcomes from the iPPG arm against those from the combined qualitative and quantitative assessments in the ICG arm.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Linglong Yingcheng Hospital, High-Tech Clinic Beloostrov
- Responsible party
- Principal investigator, Xuan Qiu, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222645
- Sponsor's protocol ID
- spbuippg001
- Status last verified
- Nov 2025
- First submitted
- 21 Dec 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections
- ClinicalTrials.gov ID
- NCT06222645
- Acronym / sponsor ID
- spbuippg001
- Conditions
- Anastomosis, Perfusion, Postoperative Complications, Gastrointestinal Neoplasms, Gastric Cancer (GC), Colorectal Cancer
- Keywords
- Photoplethysmography, Indocyanine Green, Fluorescence Imaging, Anastomotic Leak, Gastrointestinal Surgery, Tissue Perfusion, Intraoperative Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Collaborators
- Shandong Linglong Yingcheng Hospital, High-Tech Clinic Beloostrov
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a randomized, parallel-group design. Participants are randomly allocated to one of two distinct intraoperative assessment arms: 1. iPPG Arm: Perfusion assessment is guided solely by the investigational Imaging Photoplethysmography (iPPG) system. 2. ICG Arm: Perfusion assessment is guided by the standard Indocyanine Green (ICG) fluorescence imaging. The evaluation within this arm is comprehensive, encompassing both qualitative assessment (real-time visual interpretation of the angiogram by the surgeon) and quantitative analysis (software-based kinetics of the fluorescence intensity). The primary comparative analysis will benchmark the outcomes from the iPPG arm against those from the combined qualitative and quantitative assessments in the ICG arm.
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green (ICG) imaging system | Active comparator | Drug: ICG fluorescence imaging technology, Device: Imaging Photoplethysmography SystemParticipants 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) | Experimental | Drug: ICG fluorescence imaging technology, Device: Imaging Photoplethysmography SystemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG fluorescence imaging technologyAlso: ICG Imaging, ICG Angiography, Near-Infrared Fluorescence ImagingThis 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. | Drug | Indocyanine green (ICG) imaging system, imaging photoplethysmography (iPPG) |
| Imaging Photoplethysmography SystemAlso: iPPG, PPG ImagingImaging 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. | Device | Indocyanine green (ICG) imaging system, imaging photoplethysmography (iPPG) |
Primary outcome
Incidence of Anastomotic Leak
Time frame: 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
Time frame: 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.
4 secondary outcomes
Diagnostic Performance for Predicting Anastomotic Leak
Time frame: he perfusion assessment is performed intraoperatively. The outcome (anastomotic leak) is assessed at 30 days postoperatively.
Rate of Anastomotic Revision Based on Perfusion Assessment
Time frame: Intraoperative (Measured immediately following the perfusion assessment of the initially constructed anastomosis)
Overall Postoperative Complication Rate
Time frame: 30 days postoperatively
Rate of Re-intervention
Time frame: 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG fluorescence imaging technology and Imaging Photoplethysmography System in people with Anastomosis and Perfusion, run by Saint Petersburg State University, Russia at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuan - Qiu, MD (79643411524, st122986@student.spbu.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Anastomotic Leak (time frame: 30 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.