[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533194":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":39,"locations":49,"responsibleParty":84,"collaborators":88,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":38,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":38,"enrollmentInfo":102,"targetDuration":38,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":116,"overallStatus":52,"whyStopped":38,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Saint Petersburg State University, Russia","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: ICG fluorescence imaging technology","Device: Imaging Photoplethysmography System",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",[13,14],[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ICG fluorescence imaging technology","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.",[9,16],[27,28,29],"ICG Imaging","ICG Angiography","Near-Infrared Fluorescence Imaging",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","Imaging Photoplethysmography System","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.",[9,16],[36,37],"iPPG","PPG Imaging",null,[40,45],{"name":41,"role":42,"phone":43,"phoneExt":38,"email":44},"Xuan - Qiu, MD","CONTACT","79643411524","st122986@student.spbu.ru",{"name":46,"role":42,"phone":47,"phoneExt":38,"email":48},"Victor A. Kashchenko, MD,PD","79119289525","surg122@yandex.ru",[50,69,77],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Shandong Linglong Yingcheng Hospital","RECRUITING","Yantai","Shandong","265400","China","CN",{"type":59,"coordinates":60},"Point",[61,62],121.44081,37.47649,{"lat":62,"lon":61},[65],{"name":66,"role":42,"phone":67,"phoneExt":38,"email":68},"Xuan Qiu, MD","8618354280081","qiuxuan100@163.com",{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"High-Tech Clinic Beloostrov","ACTIVE_NOT_RECRUITING","Saint Petersburg","Leningradskaya Oblast'","197729","Russia","RU",{"facility":78,"status":52,"city":72,"state":73,"zip":79,"country":75,"countryCode":76,"cosmosGeoPoint":38,"geoPoint":38,"contacts":80},"Department of Faculty Surgery, Saint Petersburg State University","199034",[81],{"name":82,"role":42,"phone":83,"phoneExt":38,"email":68},"Xuan Qiuxuan, MD","79643511524",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Xuan Qiu","Principal Investigator",[89,91],{"name":51,"class":90},"NETWORK",{"name":70,"class":92},"UNKNOWN","100533194","ppg-vs-icg-in-gastrointestinal-resections-100533194",false,"NCT06222645","PPG vs. ICG in Gastrointestinal Resections","Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years).\n* Scheduled to undergo an elective gastrointestinal resection requiring a primary gastro-intestinal or entero-enteric anastomosis.\n* Able to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to indocyanine green (ICG), iodine, or any component of the ICG formulation.\n* Severe hepatic impairment (e.g., Child-Pugh Class C).\n* Pregnancy or lactation.\n* Emergency surgery.\n* Inability to comply with the study protocol or follow-up schedule in the investigator's judgment.","ALL","18 Years",{"count":103,"type":104},200,"ESTIMATED","INTERVENTIONAL",[107],"NA","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.",[110,111,112,113,114,115],"Anastomosis","Perfusion","Postoperative Complications","Gastrointestinal Neoplasms","Gastric Cancer (GC)","Colorectal Cancer",[117,118,119,120,121,122,123],"Photoplethysmography","Indocyanine Green","Fluorescence Imaging","Anastomotic Leak","Gastrointestinal Surgery","Tissue Perfusion","Intraoperative Monitoring","2025-11-14",{"date":126,"type":127},"2025-11-18","ACTUAL",{"date":129,"type":127},"2023-11-01",{"date":131,"type":104},"2026-05-31",{"name":5,"class":6},3]