[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578847":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":20,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with bile duct disease not eligible for endoscopic treatment","EXPERIMENTAL","Before the procedure all patients will be submitted to US and\u002For CT and\u002For MRI and will be evaluated for hemoglobin, hematocrit and liver function tests. Patients with biliary tract disorders that are not eligible for endoscopic treatment and\u002For previous failed endoscopic treatment will be evaluated for inclusion in this study. Therefore, a case-by-case discussion will be conducted with the reference hepatologists\u002Fsurgeons to assess treatment assignment. Once enrolled in the study, patients will undergo cholangioscopic-assisted treatment at the UOC addomino-pelvic diagnostic and interventional radiology unit of the Bologna University Hospital. After the procedure, patients will be required to perform a clinical laboratory monitoring in subsequent follow-up controls that will be performed 3-6-12-24-36 months after treatment. Additional imaging examinations (US, CT or MRI) will only be scheduled if symptoms recur.",[13],"Procedure: Percutaneous cholangioscopic-assisted treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Percutaneous cholangioscopic-assisted treatment","The intervention administered is a percutaneous colangioscopic assisted technique that uses endoscopic Spyglass system. The endoscopic Spyglass system is designed to provide direct viewing and to guide both optical devices and accessories for lithotripsy in case of litiasic pathology and is equipped with a suitable bioptic clamp in case of biopsy collection. The use of the digital Spyglass catheter involves the preliminary percutaneous puncture of the bile ducts with a right, left or combined approach, and the subsequent execution of a cholangiographic study. Additional treatment sessions may be performed every 15-20 days in case of residual lithiasis. At the end of each session, an internal-external transeptic percutaneous drainage (ptbd) of adequate caliber (8-14 fr) is left in place to monitor any complications and maintain a route of access for sequential treatments.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Alberta Cappelli, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+39 051 6362598","alberta.cappelli@aosp.bo.it",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Bologna","BO","40138","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],11.33875,44.49381,{"lat":42,"lon":41},[45],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100578847","diagnosis-and-percutaneous-treatment-of-biliary-tract-diseases-100578847",false,"NCT06816615","Diagnosis and Percutaneous Treatment of Biliary Tract Diseases","Inclusion Criteria:\n\n* Radiological diagnosis of indeterminate gallstones or stenosis of the bile ducts not eligible for endoscopic treatment and\u002For previous failed endoscopic treatment\n* Good liver function (hemoglobin, hematocrit, GOT, GPT, GGT within normal ranges)\n* Age over 18\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* presence of severe untreatable coagulopathies","ALL","18 Years",{"count":57,"type":58},24,"ESTIMATED","INTERVENTIONAL",[61],"NA","This study aims to implement and optimize the treatment of bile duct diseases in participants not eligible for endoscopic treatment using the Spyglass system, a system suitable for diagnostic and therapeutic endoscopic procedures in the pancreatic-biliary system, including the hepatic ducts.\n\nThe main question it aims to answer is:\n\n\\- Can the percutaneous cholangioscopic assisted technique resolve the biliary litiasis and\u002For perform endobiliary biopsies in less time than the traditional technique?\n\nParticipants will undergo a colangioscopic-assisted treatment using the SpyGlass mini-endoscopic system at the Addomino-pelvic diagnostic and interventional radiology UOC of the Bologna University Hospital.",[64,65,66],"Gallstone","Biliary Stricture","Biliary Diseases","2025-02-04",{"date":69,"type":70},"2025-02-10","ACTUAL",{"date":72,"type":70},"2022-10-14",{"date":74,"type":58},"2027-01",{"name":5,"class":6},1]