[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443997":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":73,"collaborators":28,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":28,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":28,"overallStatus":46,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"short sphincterotomy +Short duration papillary large balloon dilation","ACTIVE_COMPARATOR","Patients with short sphincterotomy",[13],"Device: endoscopic short duration papillary large balloon dilation",{"label":15,"type":10,"description":16,"interventionNames":17},"full sphincterotomy + short duration papillary balloon dilation","Patients with full lenght sphincterotomy",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"previous sphincterotomy + short duration papillary balloon dilation","Patients with previous sphincterotomy",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","endoscopic short duration papillary large balloon dilation","During the large balloon papillary dilation investigators follow the cholangiogram and stop the dilatation as soon as the disappearance of the waist of the papilla is noticed.",[15,19,9],null,[30],{"name":31,"affiliation":5,"role":32},"Mia Rainio, Md, PhD","STUDY_DIRECTOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Mia Rainio, MD, PhD","CONTACT","+358505833060","mia.rainio@hus.fi",{"name":40,"role":36,"phone":41,"phoneExt":28,"email":42},"Leena Kylänpää, MD, PhD","+35894711","leena.kylanpaa@hus.fi",[44,60],{"facility":45,"status":46,"city":47,"state":28,"zip":28,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Helsinki University Hospital","RECRUITING","Helsinki","Finland","FI",{"type":51,"coordinates":52},"Point",[53,54],24.93545,60.16952,{"lat":54,"lon":53},[57,58],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},{"name":59,"role":36,"phone":41,"phoneExt":28,"email":42},"Leena Kylänpää, Md PhD",{"facility":61,"status":46,"city":62,"state":28,"zip":28,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Turku University Hospital","Turku",{"type":51,"coordinates":64},[65,66],22.26869,60.45148,{"lat":66,"lon":65},[69],{"name":70,"role":36,"phone":71,"phoneExt":28,"email":72},"Juha Grönroos, Professor","+358 2 3130000","juha.gronroos@tyks.fi",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Mia Rainio","Principal Investigator","100443997","quick-large-balloon-dilatation-for-removal-of-large-bile-duct-stones-shodbadi-100443997",false,"NCT05061680","Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)","Endoscopic Papillary Short Duration Large Balloon Dilatation for Removal of Large Bile Duct Stones: a Prospective Multicenter Study of Short and Long-term Adverse Events","SHODBADI","Inclusion Criteria:\n\n* Age \\>18 years\n* Common bile duct stone \\>10mm diameter\n\nExclusion Criteria:\n\n* Altered anatomy after surgery (B II, Roux-en-Y reconstruction)\n* Common bile duct cysts\n* Acute pancreatitis\n* Distal common bile duct stricture or tumor\n* Coagulation disorders\n* Ongoing coagulation medication\n* Pregnancy\n* Inability to give an informed consent","ALL","18 Years","95 Years",{"count":89,"type":90},600,"ESTIMATED","INTERVENTIONAL",[93],"NA","ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla.\n\nThe investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. This Scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.",[96,97,98],"Pancreatitis, Acute","Bleeding","Cholangitis","2023-02-28",{"date":101,"type":102},"2023-03-01","ACTUAL",{"date":104,"type":102},"2021-04-05",{"date":106,"type":90},"2026-12-31",{"name":5,"class":6},2]