[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640173":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":38,"collaborators":11,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":11},{"fullName":5,"class":6},"Société Française d'Endoscopie Digestive","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).","EXPERIMENTAL",null,[13],"Device: EYEMAX® cholangioscopy system",{"label":15,"type":16,"description":11,"interventionNames":17},"Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).","ACTIVE_COMPARATOR",[18],"Device: SPYGLASS™ DS system",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","EYEMAX® cholangioscopy system","Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the EYEMAX® working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"SPYGLASS™ DS system","Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS cholangioscopy system (Boston Scientific) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the SPYGLASS™ DS working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"David KARSENTI, MD","CONTACT","+33 1 43 96 78 50","karsenti.paris@gmail.com",{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},"MORENO MAIRA, PhD","rechercheclinique@sfed.org",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","David KARSENTI","Principal Investigator, Medical doctor","100640173","eyemax-versus-spyglass-ds-for-biliary-stricture-diagnosis-100640173",false,"NCT07620080","EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis","Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS","EYE\u002FSPY","Inclusion Criteria:\n\n* 1\\. Adult patients aged 18 to 84 years\n* 2\\. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture\n* 3\\. Absence of a mass easily accessible to EUS-guided fine needle aspiration\n* 4\\. ASA physical status 1-3\n* 5\\. No participation in another clinical trial\n* 6\\. Written informed consent obtained\n* 7\\. Patient affiliated with a social security system or equivalent\n\nExclusion Criteria:\n\n* 1\\. Lithiasic biliary obstruction\n* 2\\. Patients younger than 18 years\n* 3\\. ASA 4 or ASA 5 patients\n* 4\\. Pregnant or breastfeeding women\n* 5\\. Coagulation disorders preventing biopsy procedures\n* 6\\. Surgical anatomy preventing papillary access\n* 7\\. Patients unable to provide informed consent\n* 8\\. Upper gastrointestinal obstruction\n* 9\\. Intolerance to endoscopy\n* 10\\. Severe cardiopulmonary disease\n* 11\\. Acute pancreatitis or severe cholangitis\n* 12\\. Severe contrast agent allergy\n* 13\\. Patients under legal protection measures","ALL","18 Years","84 Years",{"count":54,"type":55},120,"ESTIMATED","INTERVENTIONAL",[58],"NA","Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps.\n\nThe EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures.\n\nThe primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.",[61,62],"Cholangiocarcinoma","Biliary Stricture",[64,65,66,67,68,69],"Cholangioscopy","ERCP","EYEMAX","SpyGlass DS","Biliary biopsy","Cholangiocarcinoma diagnosis","NOT_YET_RECRUITING","2026-05-26",{"date":73,"type":74},"2026-06-02","ACTUAL",{"date":76,"type":55},"2026-09",{"date":78,"type":55},"2030-09",{"name":40,"class":6}]