[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653078":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":16,"studyPopulation":16,"armGroups":49,"interventions":62,"overallOfficials":16,"centralContacts":71,"locations":77,"responsibleParty":96,"collaborators":16,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":16,"enrollmentInfo":110,"targetDuration":16,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":124,"whyStopped":16,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Post-ERCP Pancreatitis (PEP)","Occurrence of post-ERCP pancreatitis within 48 hours after ERCP, defined according to the revised Atlanta criteria: ≥2 of the following: (a) characteristic abdominal pain; (b) serum amylase or lipase \\>3× upper limit of normal; (c) imaging findings consistent with pancreatitis.","48 hours after ERCP",[14,18,22,25,27,31,34],{"measure":15,"description":16,"timeFrame":17},"Incidence of Post-ERCP Pancreatitis within 30 days",null,"Within 30 days after ERCP",{"measure":19,"description":20,"timeFrame":21},"Severity of PEP","Severity of Post-ERCP Pancreatitis± According to the revised Atlanta classification (mild, moderate, severe)","Up to 30 days after ERCP",{"measure":23,"description":24,"timeFrame":21},"ERCP-related complications","Incidence of ERCP-related complications other than PEP",{"measure":26,"description":16,"timeFrame":21},"Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Reactions",{"measure":28,"description":29,"timeFrame":30},"Hospital\u002FICU stay","Length of hospital and ICU stay","Up to 12 weeks",{"measure":32,"description":16,"timeFrame":33},"Change in quality of life as measured by EQ-5D-5L","Baseline, 48 hours, and 12 weeks after ERCP",{"measure":35,"description":36,"timeFrame":37},"Healthcare costs","Healthcare consumption and societal costs","Up to 12 weeks after ERCP",{"allocation":39,"interventionModel":40,"interventionModelDescription":16,"primaryPurpose":41,"observationalModel":16,"timePerspective":16,"maskingInfo":42},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":43,"maskingDescription":16,"whoMasked":44},"QUADRUPLE",[45,46,47,48],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Tacrolimus","EXPERIMENTAL","Participants receive a single intravenous dose of tacrolimus, completed before the start of ERCP. All participants also receive standard prophylactic care with rectal diclofenac 100 mg.",[55],"Drug: Tacrolimus",{"label":57,"type":58,"description":59,"interventionNames":60},"Placebo","PLACEBO_COMPARATOR","Participants receive a matching intravenous placebo, identical in appearance and administration to the tacrolimus arm. All participants also receive standard prophylactic care with rectal diclofenac 100 mg.",[61],"Other: NaCl (placebo)",[63,67],{"type":64,"name":51,"description":65,"armGroupLabels":66,"otherNames":16},"DRUG","A single intravenous dose of tacrolimus, completed before the start of ERCP.",[51],{"type":6,"name":68,"description":69,"armGroupLabels":70,"otherNames":16},"NaCl (placebo)","A matching intravenous placebo, identical in appearance and administration to the tacrolimus infusion.",[57],[72],{"name":73,"role":74,"phone":75,"phoneExt":16,"email":76},"Malin Witteman, MD","CONTACT","+31 88 3207054","m.witteman1@amsterdamumc.nl",[78],{"facility":79,"status":16,"city":80,"state":16,"zip":16,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Amsterdam UMC, Location VUmc","Amsterdam","Netherlands","NL",{"type":84,"coordinates":85},"Point",[86,87],4.88969,52.37403,{"lat":87,"lon":86},[90,93],{"name":91,"role":74,"phone":92,"phoneExt":16,"email":76},"Malin Witteman","088-3207054",{"name":94,"role":95,"phone":16,"phoneExt":16,"email":16},"Mattheus Wielenga, MD PhD","PRINCIPAL_INVESTIGATOR",{"type":95,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Mattheus Wielenga","MD PhD","100653078","phase-4-tacrolimus-as-prophylaxis-of-post-ercp-pancreatitis-100653078",false,"NCT07781722","Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis","Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis: a DPSG (Dutch Pancreatitis Study Group) Multicenter, Double-blind, Randomized, Placebo-controlled Study.","TacroProph","Inclusion Criteria:\n\n* Age 18 years or older\n* Indication for ERCP\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Previous sphincterotomy or sphincteroplasty\n* Routine biliary stent exchange\n* Altered anatomy or biliodigestive anastomosis\n* Chronic pancreatitis according to the M-ANNHEIM criteria\n* Active pancreatitis\n* Sepsis or ASA IV\n* Contraindication for tacrolimus or diclofenac (allergy, potassium \\>5 mmol\u002FL, eGFR \\\u003C30 mL\u002Fmin)\n* Pregnancy or breastfeeding\n* Current tacrolimus or ciclosporin use\n* Current use of medications contraindicated with tacrolimus, including strong CYP3A4\u002F3A5 inhibitors (e.g., ketoconazole, voriconazole, posaconazole, itraconazole, clarithromycin, josamycin, ritonavir, cobicistat) or CYP3A4\u002F3A5 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort)",true,"ALL","18 Years",{"count":111,"type":112},520,"ESTIMATED","INTERVENTIONAL",[115],"PHASE4","The goal of this clinical trial is to learn if a single intravenous dose of tacrolimus, given before an ERCP procedure (an endoscopic procedure of the bile ducts and pancreas), can prevent post-ERCP pancreatitis (PEP) in adults at moderate-to-high risk of developing this complication.\n\nThe main question it aims to answer is:\n\n* Does a single dose of tacrolimus lower the number of participants who develop pancreatitis after ERCP?\n\nResearchers will compare tacrolimus to a placebo (a look-alike solution with no active drug) to see if tacrolimus reduces the occurrence of PEP.\n\nParticipants will:\n\n* Receive an intravenous infusion of either tacrolimus or placebo, given over 60 minutes, ending before the start of the ERCP procedure\n* Receive standard preventive treatment (a rectal anti-inflammatory medication (NSAID)) in addition to the study infusion\n* Be contacted by phone 48 hours after the procedure to check for symptoms\n* Complete questionnaires about quality of life and healthcare use, and be followed for 12 weeks after the procedure\n* The first 40 enrolled patients will have extra blood samples taken to measure tacrolimus levels.",[118],"Post-ERCP Pancreatitis",[120,51,121,122,123],"Post-ERCP pancreatitis","Endoscopic retrograde cholangiopancreatography","Prophylaxis","ERCP","NOT_YET_RECRUITING","2026-08-19",{"date":127,"type":128},"2026-08-24","ACTUAL",{"date":130,"type":112},"2026-09-07",{"date":132,"type":112},"2028-12-07",{"name":5,"class":6},1]