[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459804":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PEP patients",null,"Patients who develop PEP",[13],"Diagnostic Test: Take blood samples",{"label":15,"type":10,"description":16,"interventionNames":17},"Control cohort","Patients who do not develop PEP",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Take blood samples","Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.",[15,9],[25],{"name":26,"affiliation":5,"role":27},"Erwin van Geenen, MD, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Mike de Jong, MD","CONTACT","0031883207054","mike.dejong@radboudumc.nl",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RadboudUMC","RECRUITING","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],5.85278,51.8425,{"lat":47,"lon":46},[50,51],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},{"name":26,"role":31,"phone":52,"phoneExt":10,"email":53},"0031243619190","erwin.vangeenen@radboudumc.nl",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100459804","an-european-multi-centre-cohort-study-for-unravelling-pharmacokinetic-and-genetic-factors-underlying-post-ercp-pancreatitis-100459804",false,"NCT05267379","An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis","G-PEP","Inclusion Criteria:\n\n* Age ≥ 18 years\n* written informed consent\n* Indication to undergo an ERCP\n\nExclusion Criteria:\n\n* Pancreatic cancer\n* Chronic pancreatitis\n* Ongoing acute pancreatitis\n* Altered anatomy, defined as anatomical variations in which gall and\u002For pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.","ALL","18 Years",{"count":66,"type":67},700,"ESTIMATED","OBSERVATIONAL","Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.",[71],"Post-ERCP Acute Pancreatitis","2025-04-18",{"date":74,"type":75},"2025-04-23","ACTUAL",{"date":77,"type":75},"2022-03-01",{"date":79,"type":67},"2027-12-01",{"name":5,"class":6},1]