[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Westmead Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100652690","short-stay-aggressive-hydration-to-prevent-post-ercp-pancreatitis-100652690",false,"NCT07776561","Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis","Preventing Post ERCP Pancreatitis by Short Stay Aggressive Hydration (PuSH) -a Prospective Randomized Trial.","PuSH","Inclusion Criteria:\n\n* Age over 18 years\n* Undergoing ERCP\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to give consent\n* Clinical signs\u002Fsymptoms of congestive cardiac failure (pitting oedema, NYHA class ≥ 2, or oxygen saturation ≤ 90%)\n* Respiratory failure (pre-procedure SpO2 \\\u003C 90% on room air, or requirement for non-invasive\u002Fmechanical ventilation)\n* Contraindication to rectal NSAIDs (allergy; active gastrointestinal bleeding)\n* Estimated GFR (MDRD) ≤ 30 mL\u002Fmin\n* Altered biliary or duodenal anatomy (e.g. prior biliary\u002Fpancreatic surgery, Roux-en-Y reconstruction)\n* Known hypo- or hypernatraemia (serum sodium \\\u003C 130 or \\> 150 mmol\u002FL)\n* Pregnancy\n* Severe liver disease (cirrhosis with ascites)\n* Previous sphincterotomy (unless undergoing pancreatic duct intervention)\n* Acute pancreatitis\n* Chronic pancreatitis (unless undergoing a pancreatic duct intervention)\n* Sphincter of Oddi dysfunction\n* Pancreatic mass causing biliary obstruction","ALL","18 Years",{"count":20,"type":21},1300,"ESTIMATED","INTERVENTIONAL",[24],"NA","Post-ERCP pancreatitis (PEP) is the most common serious adverse event after endoscopic retrograde cholangiopancreatography (ERCP), occurring in roughly 7-15% of patients. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and peri-procedural aggressive intravenous hydration each reduce PEP, but published hydration regimens are delivered over 8-24 hours and require an overnight hospital stay, which is impractical where ERCP is increasingly performed as a same-day procedure.\n\nThis multicentre, prospective, randomised controlled trial tests whether a short (under 4 hours) aggressive hydration regimen with Lactated Ringer's solution, combined with rectal indomethacin, is superior to standard care (rectal indomethacin plus low-volume hydration) for preventing PEP, while supporting same-day discharge. Adults undergoing ERCP are randomised 1:1. The primary outcome is the incidence of PEP defined by consensus (Cotton) criteria. A total of 1300 participants (650 per arm) will be enrolled.",[27,28],"Post-ERCP Pancreatitis","Pancreatitis",[30,31,32,33,34,35,36],"ERCP","Post-ERCP pancreatitis","Aggressive hydration","Lactated Ringer's solution","Rectal indomethacin","Fluid resuscitation","Same-day discharge","RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-20","ACTUAL",{"date":43,"type":41},"2026-06-01",{"date":45,"type":21},"2029-06-01",{"name":47,"class":48},"Westmead Hospital","OTHER",""]