[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436561":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":24,"studyPopulation":13,"armGroups":25,"interventions":36,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":73,"collaborators":13,"id":77,"slug":13,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":13,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":13,"enrollmentInfo":85,"targetDuration":13,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":58,"whyStopped":13,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"China Medical University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"post EST bleeding rate","delay post-sphincterotomy bleeding rate","30 days",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":19,"maskingDescription":13,"whoMasked":20},"TRIPLE",[21,22,23],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","Backgroud:\n\nBleeding 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.\n\nStudy Rationale:\n\nThe hypotheses of the study is the prophylactic saline-epinephrine solution injection affects incidence of delayed post-EST bleeding.\n\nStudy Design:\n\nA single blinded parallel group, multiple center, randomized controlled trial. The sample size is estimated 400 (200 in injection group and 200 in non-injection group), The primary outcome is the rate of delayed EST bleeding within 30 days of ERCP.\n\nStudy Objectives:\n\nPrimary objective: the rate of post-EST bleeding within 30 days of ERCP Secondary objectives: the rate of post-ERCP advese effect, the increasing procedure time because of hemostasis, the need for angiographic\u002Fendoscopic hemostasis times.",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"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.",[31],"Procedure: epinephrine solution injection",{"label":33,"type":34,"description":35,"interventionNames":13},"non-injection group","NO_INTERVENTION","In non injection group, the saline epinephrine solution is not given",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"PROCEDURE","epinephrine solution injection","epinephrine solution injection at least 1 ml to the post- sphincterotomy wound",[27],[43],{"name":44,"affiliation":5,"role":45},"Wen-Hsin Huang, MD","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":13,"email":51},"Shih-Chieh Chuang, MD","CONTACT","+886-975680839","D18114@mail.cmuh.org.tw",{"name":44,"role":49,"phone":53,"phoneExt":54,"email":55},"+886-4-2205-2121","2233","u97766.huang@msa.hinet.net",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Taichung","North Dist.","404332","Taiwan","TW",{"type":65,"coordinates":66},"Point",[67,68],120.6839,24.1469,{"lat":68,"lon":67},[71],{"name":48,"role":49,"phone":50,"phoneExt":13,"email":72},"D18114@mail.cmuh.org",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"SPONSOR_INVESTIGATOR","Wen-Hsin Huang","Gastroenterology and Hepatology Deputy Director","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":86,"type":87},400,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93],"Bleeding Hemorrhage",[95,96],"sphincterotomy","epinephrine solution","2024-10-22",{"date":99,"type":100},"2024-10-24","ACTUAL",{"date":102,"type":100},"2021-07-15",{"date":104,"type":87},"2030-12",{"name":75,"class":6},1]