[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649688":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":65,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":24,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":24,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Instituto do Cancer do Estado de São Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NSAID alone","ACTIVE_COMPARATOR","Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.",[13],"Procedure: NSAID alone",{"label":15,"type":16,"description":17,"interventionNames":18},"Cryoprevention associated with NSAID","EXPERIMENTAL","Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).",[19],"Procedure: Cryoprevention associated with NSAID",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"PROCEDURE",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":30,"role":31},"Fauze Maluf Filho","Hospital das Clínicas da Universidade de São Paulo","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Prof. Dr. Fauze Maluf Filho","CONTACT","+55 11 99191-9014","fauze.maluf@terra.com.br",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"Dr. Mateus Bond Boghossian","+55 11 91795-4571","matbogho@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil.","RECRUITING","São Paulo","05403-000","Brazil","BR",{"type":51,"coordinates":52},"Point",[53,54],-46.63611,-23.5475,{"lat":54,"lon":53},[57,58,59,60,63],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":39,"role":35,"phone":24,"phoneExt":24,"email":41},{"name":29,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":61,"role":62,"phone":24,"phoneExt":24,"email":24},"Mateus Bond Boghossian","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":24,"phoneExt":24,"email":24},"João Guilherme Ribeiro Jordão Sasso",{"type":31,"investigatorFullName":29,"investigatorTitle":66,"investigatorAffiliation":67,"oldNameTitle":24,"oldOrganization":24},"Director of the Endoscopy Unit at the São Paulo Cancer Institute (ICESP) and HCFMUSP","University of Sao Paulo","100649688","cold-and-nsaid-trial-for-prevention-of-post-ercp-pancreatitis-100649688",false,"NCT07738094","Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis","Comparison Between Local Cryoprevention Associated With NSAIDs Versus NSAIDs Alone for Reducing the Incidence of Post-ERCP Pancreatitis: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Clinical indication for ERCP\n* Presence of native major duodenal papilla without previous manipulation\n* Ability of the patient or companion to provide informed consent.\n\nExclusion Criteria:\n\n* Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation)\n* Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved)\n* Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions)\n* Pregnant women\n* Refusal to participate in the study or inability to sign the ICF\n* Contraindication to NSAID use.","ALL","18 Years",{"count":78,"type":79},462,"ESTIMATED","INTERVENTIONAL",[82],"NA","The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.",[85],"Pancreatitis, Acute",[87,88,89,90],"Post-ERCP Pancreatitis","Cryoprevention","ERCP","NSAIDs","2026-07-29",{"date":93,"type":94},"2026-07-30","ACTUAL",{"date":96,"type":94},"2026-06-09",{"date":98,"type":79},"2028-08-31",{"name":5,"class":6},1]