[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100340543":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":158,"collaborators":161,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":27,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":27,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":51,"whyStopped":27,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"indomethacin","EXPERIMENTAL","rectal indomethacin 100 mg to be administered before or after ERCP",[13],"Drug: Indomethacin",{"label":15,"type":10,"description":16,"interventionNames":17},"pancreatic stenting","a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025\" or .035\" wire)",[18],"Device: pancreatic stenting",{"label":20,"type":10,"description":21,"interventionNames":22},"indomethacin plus pancreatic stenting","\\[rectal indomethacin 100 mg to be administered before or after ERCP\\] plus \\[a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025\" or .035\" wire\\]",[18,13],[24,28],{"type":25,"name":15,"description":16,"armGroupLabels":26,"otherNames":27},"DEVICE",[20,15],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Indomethacin","rectally administered indomethacin before or after ERCP",[9,20],[34],"indocid",[36],{"name":37,"affiliation":5,"role":38},"James LAU, MD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":27,"email":43},"CONTACT","35051411","laujyw@surgery.cuhk.edu.hk",{"name":45,"role":41,"phone":46,"phoneExt":27,"email":47},"RAYMOND TANG, MD","35052640","raymondtang@cuhk.edu.hk",[49,72,88,99,113,128,141],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Endoscopy centre","RECRUITING","Xi'an","Shaanxi","710000","China","CN",{"type":58,"coordinates":59},"Point",[60,61],108.92861,34.25833,{"lat":61,"lon":60},[64,67,70],{"name":65,"role":41,"phone":27,"phoneExt":27,"email":66},"Yang Lin Pan, MD","panyl@fmmu.edu.cn",{"name":68,"role":69,"phone":27,"phoneExt":27,"email":27},"Pang Yang Lin, MD","SUB_INVESTIGATOR",{"name":71,"role":38,"phone":27,"phoneExt":27,"email":27},"Kai Chun Wu, MD",{"facility":73,"status":51,"city":74,"state":75,"zip":76,"country":55,"countryCode":56,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Eastern Hepatobiliary Surgery Hospital,Endoscopy centre","Shanghai","Shanghai Municipality","200000",{"type":58,"coordinates":78},[79,80],121.45806,31.22222,{"lat":80,"lon":79},[83,86],{"name":84,"role":41,"phone":27,"phoneExt":27,"email":85},"Bing HU, MD","drhubing@aliyun.com",{"name":87,"role":38,"phone":27,"phoneExt":27,"email":27},"Bing Hu, MD",{"facility":50,"status":89,"city":74,"state":75,"zip":76,"country":55,"countryCode":56,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"NOT_YET_RECRUITING",{"type":58,"coordinates":91},[79,80],{"lat":80,"lon":79},[94,97],{"name":95,"role":41,"phone":27,"phoneExt":27,"email":96},"Yu Bai, MD","baiyu1998@hotmail.com",{"name":98,"role":38,"phone":27,"phoneExt":27,"email":27},"YU Bai, MD",{"facility":50,"status":51,"city":100,"state":101,"zip":102,"country":55,"countryCode":56,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Tianjin","Tianjin Municipality","300000",{"type":58,"coordinates":104},[105,106],117.17667,39.14222,{"lat":106,"lon":105},[109,112],{"name":110,"role":41,"phone":27,"phoneExt":27,"email":111},"Wen Li, MD","drliwen@126.com",{"name":110,"role":38,"phone":27,"phoneExt":27,"email":27},{"facility":50,"status":51,"city":114,"state":115,"zip":116,"country":55,"countryCode":56,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hangzhou","Zhejiang","310013",{"type":58,"coordinates":118},[119,120],120.16142,30.29365,{"lat":120,"lon":119},[123,126],{"name":124,"role":41,"phone":27,"phoneExt":27,"email":125},"Yun Sheng Qing, MD","175260446@qq.com",{"name":127,"role":38,"phone":27,"phoneExt":27,"email":27},"Yun sheng Qing, MD",{"facility":129,"status":51,"city":130,"state":130,"zip":27,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Endoscopy Centre, Prince of Wales Hospital","Hong Kong","HK",{"type":58,"coordinates":133},[134,135],114.17469,22.27832,{"lat":135,"lon":134},[138],{"name":139,"role":41,"phone":140,"phoneExt":27,"email":43},"James Y LAU, Prof","+85235051411",{"facility":142,"status":51,"city":143,"state":27,"zip":27,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"2. Chulalongkorn University and King Chulalongkorn Memorial Hospital","Bangkok","Thailand","TH",{"type":58,"coordinates":147},[148,149],100.50144,13.75398,{"lat":149,"lon":148},[152,155],{"name":153,"role":41,"phone":27,"phoneExt":27,"email":154},"Supakarn Chaithongrat, MD","pangicu@hotmail.com",{"name":156,"role":41,"phone":27,"phoneExt":27,"email":157},"Parit Mekaroonkamol, MD","parit_m@hotmail.com",{"type":38,"investigatorFullName":159,"investigatorTitle":160,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"James Yun-wong Lau, MD","Professor",[162,164,166,168,170],{"name":163,"class":6},"Xijing Hospital",{"name":165,"class":6},"Changhai Hospital",{"name":167,"class":6},"Tianjin Union Medical Center",{"name":169,"class":6},"Zhejiang University",{"name":171,"class":6},"Eastern Hepatobiliary Surgery Hospital","100340543","phase-3-comparative-effectiveness-between-indomethacin-and-pancreatic-stenting-in-the-prevention-of-post-ercp-pancreatitis-100340543",false,"NCT03713879","Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis","Comparative Effectiveness Between Rectally Administered Indomethacin and Pancreatic Stenting in the Prevention of Post Endoscopic Retrograde Cholangio-panceaticography (ERCP) Pancreatitis: a Randomized Trial","Inclusion Criteria:\n\npresence of one of the following risk factors for Post ERCP Pancreatitis\n\n1. sphincter of Oddi dysfunction\n2. history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,\n3. difficult cannulation defined by \\>5 cannulation attempts\n4. the use of double wire technique in bile duct access\n5. at least 2 of the followings including i) female age\\\u003C50 ii) 3 pancreatograms iii) acinarization (contrast injection to tail fo pancreas). iv） normal bilirubin； v）guidewire to the tail of pancreas or secondary branches.\n\nExclusion Criteria:\n\n* patients intended for pancreatic stenting e.g. those with pancreatic duct strictures, ampullectomy,\n* without informed consents from patient or next of kin\n* age \\\u003C18\n* pregnant or lactating women\n* patients with altered anatomy except except Billroth I and II gastrectomy\n* contraindications to the use of NSAIDs such as those with active gastrointestinal bleeding, renal failure (serum creatinine \\> 140)\n* known NSAID allergy\n* incipient heart failure.","ALL","18 Years","99 Years",{"count":183,"type":184},1734,"ESTIMATED","INTERVENTIONAL",[187],"PHASE3","Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.",[190],"Post ERCP Pancreatitis",[192,193,194],"post ERCP panceatitis","rectal indomethacin","pancreatic stents","2025-02-10",{"date":197,"type":198},"2025-02-12","ACTUAL",{"date":200,"type":198},"2019-03-21",{"date":202,"type":184},"2026-12-31",{"name":5,"class":6},7]