[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431756":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":127,"collaborators":25,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":25,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":25,"enrollmentInfo":139,"targetDuration":25,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Over-the-scope clips","EXPERIMENTAL","The OTSC® System Set is an instrument for flexible endoscopy\n\nThe OTSC® System Set consists of an applicator cap with a mounted OTSC® clip, thread, thread retriever and a hand wheel for clip release.\n\nThe OTSC® clip is delivered by means of an applicator cap mounted to the tip of gastroscopes or colonoscopes. The clip is released by tightening the thread with the hand wheel.\n\nThe OTSC® clip for flexible endoscopy is a superelastic Nitinol device for compression and approximation of tissue in the digestive tract",[13],"Device: The OTSC® System Set",{"label":15,"type":10,"description":16,"interventionNames":17},"angiographic embolization","The procedure was performed in the angiographic suite and under local anaesthetics to the patient's groin. The celiac and then gastroduodenal artery or the left gastric artery was selectively cannulated depending on ulcer location.\n\nCoils were deposited distal to the bleeding point. Gel foam particles were then packed into the artery and its collaterals. This was followed by further coils deposited in its proximal portion until complete cessation of arterial flow. Our protocol requested empiric embolisation of the artery even in the absence of active contrast extravasation or a pseudoaneurysm.",[18],"Procedure: angiographic embolization",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The OTSC® System Set","The endoscope was extracted and equipped with the OTSC system. OTSC system is deployed on the lesion with suction to target lesion",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"PROCEDURE","Transcatheter selective embolization to bleeding arteries",[15],[31],{"name":32,"affiliation":33,"role":34},"Yau Wong James Lau, MD","The Chinese University of HongKong","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","35052640","laujyw@surgery.cuhk.edu.hk",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Yuanyuan yu, phd","karinayu@surgery.cuhk.edu.hk",[44,65,80,94,112],{"facility":45,"status":46,"city":47,"state":48,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Beijing friendship Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58,63],{"name":59,"role":37,"phone":60,"phoneExt":61,"email":62},"PENG LI, MD","6301 4411","3482","lipeng@ccmu.edu.cn",{"name":64,"role":37,"phone":60,"phoneExt":61,"email":25},"SIUJING SUN, MD",{"facility":66,"status":46,"city":67,"state":68,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"the First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":52,"coordinates":70},[71,72],115.85306,28.68396,{"lat":72,"lon":71},[75,79],{"name":76,"role":37,"phone":77,"phoneExt":25,"email":78},"LI HU, MD","+86-791-88692748","liaoy101@126.com",{"name":25,"role":37,"phone":77,"phoneExt":25,"email":78},{"facility":81,"status":46,"city":82,"state":83,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Huaxi Hospital of Sichuan University","Chengdu","Sichuan",{"type":52,"coordinates":85},[86,87],104.06667,30.66667,{"lat":87,"lon":86},[90,92],{"name":91,"role":37,"phone":25,"phoneExt":25,"email":25},"XIAO-CUN XING, MD",{"name":93,"role":37,"phone":25,"phoneExt":25,"email":25},"XUE XIAO, MD",{"facility":95,"status":46,"city":96,"state":97,"zip":25,"country":96,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Endoscopy Centre, Prince of Wales Hospital","Hong Kong","N.T.","HK",{"type":52,"coordinates":100},[101,102],114.17469,22.27832,{"lat":102,"lon":101},[105,108],{"name":106,"role":37,"phone":107,"phoneExt":25,"email":39},"James YW LAU, MD","+852350522640",{"name":109,"role":37,"phone":110,"phoneExt":25,"email":111},"Bing-yee SUEN, MHSc","+85235052640","suenbingyee@surgery.cuhk.edu.hk",{"facility":113,"status":46,"city":114,"state":114,"zip":25,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"King Chulalongkorn Memorial Hospital","Bangkok","Thailand","TH",{"type":52,"coordinates":118},[119,120],100.50144,13.75398,{"lat":120,"lon":119},[123,125],{"name":124,"role":37,"phone":25,"phoneExt":25,"email":25},"Parit Mekaroonkamol, MD",{"name":126,"role":37,"phone":25,"phoneExt":25,"email":25},"Supakarn Chaithongrat, MD",{"type":34,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"James Yun-wong Lau, MD","Professor","100431756","otsc-vs-angiographic-embolization-in-patients-with-refractory-non-variceal-upper-gastrointestinal-bleeding-100431756",false,"NCT04902248","OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding","Endoscopic Application of Over-the-scope Clips (OTSC) vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding: a Multicenter Randomized Comparison","Inclusion Criteria:\n\n* 1\\. Patients presented with overt signs of acute upper gastrointestinal bleeding (hematemesis, melena and\u002For hypotension) 2. documented bleeding lesion at endoscopy (ulcer, dieulafoy's lesion and others), further bleeds (persistent or recurrent) after endoscopic hemostasis (thermal or hemoclips) as defined by an International Consensus Group\n\nExclusion Criteria:\n\n1. without a full informed consent from the patient or his next of kin\n2. Age \\\u003C18 years\n3. Pregnant\n4. Lactating women\n5. patients with known allergy to intravenous contrast","ALL","18 Years",{"count":140,"type":141},236,"ESTIMATED","INTERVENTIONAL",[144],"NA","In the management of patients with acute upper non-variceal upper gastrointestinal bleeding, further bleeding is the most important adverse factor predictive of mortality. In the United Kingdom Audit on acute upper gastrointestinal bleeding, clinical evidence of further bleeding was reported in 13% of patients following the first endoscopy and 27% of them died. The use of OTSC has emerged as an alternative before angiographic embolization(TAE) which is often considered most definitive.\n\nWe propose to define the algorithm in the management of patients with refractory bleeding from their peptic ulcers or other non variceal causes. We hypothesize that endoscopic use of OTSC compares favourably with TAE and both lead to similar outcomes. An equivalence of the two modalities may mean that endoscopic application of OTSC should be attempted before TAE as often we need to document further bleeds with endoscopy and a second treatment should be instituted at the same time.",[147],"Upper Gastrointestinal Bleeding",[9,15],"2026-03-16",{"date":151,"type":152},"2026-03-18","ACTUAL",{"date":154,"type":152},"2021-11-27",{"date":156,"type":141},"2026-11-30",{"name":5,"class":6},5]