[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611984":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The First Affiliated Hospital of Anhui Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"standard-dose group","ACTIVE_COMPARATOR","administration of 100 mg rectal indometacin immediately after ERCP",[13],"Drug: standard-dose group VS high-dose group",{"label":15,"type":16,"description":17,"interventionNames":18},"high-dose group","EXPERIMENTAL","administration of 200 mg rectal indometacin immediately after ERCP",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","standard-dose group VS high-dose group","A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group)",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Shaofei Wang","Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Qiao Mei, MD","CONTACT","8613865977696","meiqiaomq@aliyun.com",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Junjun Bao, MD","8613655697005","csbj01@aliyun.com",[42],{"facility":29,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hefei","Anhui","230022","China","CN",{"type":49,"coordinates":50},"Point",[51,52],117.28083,31.86389,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":57,"phoneExt":25,"email":58},"Qiming Huang, MD","8617730145813","qimhuang@163.com",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100611984","phase-4-dose-escalation-of-rectal-indomethacin-for-preventing-pep-100611984",false,"NCT07247682","Dose-escalation of Rectal Indomethacin for Preventing PEP","Dose-escalation of Rectal Indomethacin for Post-ERCP Pancreatitis Prevention in High-risk Patients: Protocol of a Multicentre Randomised Clinical Trial","Inclusion Criteria:Participants will be eligible for enrollment if they meet all of the following criteria: 1. age over 18 years; 2. classified as high risk for post-ERCP pancreatitis; 3. provision of signed, written informed consent.\n\nExclusion Criteria:Participants will be excluded if they meet any of the following conditions: 1. inaccessible major papilla; 2. surgically altered gastrointestinal anatomy; 3. current diagnosis of acute pancreatitis; 4. placement of a pancreatic stent; 5. contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including known allergy, renal insufficiency, or active peptic ulcer disease; 6. anticipated low risk of post-ERCP pancreatitis (e.g., patients with chronic calcific pancreatitis, pancreatic head mass, or those undergoing biliary interventions through a pre-existing sphincterotomy); 7.severe active cardiopulmonary disease; 8. pregnancy or breastfeeding; 9. presence of an ampullary tumor.\n\n\\-",true,"ALL","18 Years",{"count":72,"type":73},1036,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).",[79],"Post-ERCP Pancreatitis",[81,82,83],"post-ERCP pancreatitis","indometacin","ERCP","NOT_YET_RECRUITING","2025-11-18",{"date":87,"type":88},"2025-11-25","ACTUAL",{"date":90,"type":73},"2025-12-01",{"date":92,"type":73},"2028-12-30",{"name":5,"class":6},1]