[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436561":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":18,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"China Medical University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Epinephrine solution injection group","EXPERIMENTAL","In injected group, The saline epinephrine solution (1mg in 10ml N\u002FS) is injected to 2 sites of cutted papilla (1 o'clock and 11 o'clock) by injected needle, at least 0.5ml per injected site, and must be protruded from submucosal layer.",[13],"Procedure: epinephrine solution injection",{"label":15,"type":16,"description":17,"interventionNames":18},"non-injection group","NO_INTERVENTION","In non injection group, the saline epinephrine solution is not given",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","epinephrine solution injection","epinephrine solution injection at least 1 ml to the post- sphincterotomy wound",[9],[26],{"name":27,"affiliation":5,"role":28},"Wen-Hsin Huang, MD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Shih-Chieh Chuang, MD","CONTACT","+886-975680839","D18114@mail.cmuh.org.tw",{"name":27,"role":32,"phone":36,"phoneExt":37,"email":38},"+886-4-2205-2121","2233","u97766.huang@msa.hinet.net",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Taichung","North Dist.","404332","Taiwan","TW",{"type":48,"coordinates":49},"Point",[50,51],120.6839,24.1469,{"lat":51,"lon":50},[54],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":55},"D18114@mail.cmuh.org",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Wen-Hsin Huang","Gastroenterology and Hepatology Deputy Director","100436561","efficacy-of-prophylactic-epinephrine-solution-injection-in-prevention-of-delayed-post-sphincterotomy-100436561",false,"NCT04964869","Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy","Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP","Inclusion Criteria:\n\n* Age 20 years or older.\n* Ability to give informed consent.\n* An naive major papilla.\n* Transient bleeding after endoscopic sphincterotomy\n* Bleeding less than 30 secs when end of procedure\n\nExclusion Criteria:\n\n* Prior endoscopic sphincterotomy.\n* Thrombocytopenia (platelets \\\u003C50,000\u002Fmm3).\n* Liver cirrhosis (Child A-C)\n* CKD stage 4-5 and dialysis.\n* Allergy to epinephrine\n* Prolonged PT\u002FAPTT (INR\\>1.5)\n* Had exposure any antithrombotic or antiplatelet agent in recent 7 days and\u002For will take those agents in one month after EST\n* Ampulla Vater tumor\n* Active GI bleeding\n* Pregnancy\n* Limited visibility when immediate bleeding after sphincterotomy\n* Still bleeding after 30 secs when end of procedure\n* Recurrent bleeding during ERCP","ALL","20 Years",{"count":70,"type":71},400,"ESTIMATED","INTERVENTIONAL",[74],"NA","Bleeding is the most frequently reported serious complication of endoscopic sphincterotomy, and severe bleeding has occurred in about 1% to 2% of patients. Endoscopic injection of epinephrine is the most commonly used, effective, and least expensive method for the management of post- sphincterotomy bleeding. However, the efficacy of prophylactic saline-epinephrine solution injection to prevent delayed EST bleeding when transient bleeding During ERCP has not been established.",[77],"Bleeding Hemorrhage",[79,80],"sphincterotomy","epinephrine solution","2024-10-22",{"date":83,"type":84},"2024-10-24","ACTUAL",{"date":86,"type":84},"2021-07-15",{"date":88,"type":71},"2030-12",{"name":58,"class":6},1]