[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-ercp-acute-pancreatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-ercp-acute-pancreatitis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,52,76,100,126,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100641543","phase-4-indomethacin-for-biliary-ercp-patients-100641543",false,"NCT07661498","Indomethacin for Biliary ERCP Patients","Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age at the time of ERCP.\n2. Scheduled to undergo routine biliary ERCP with documentation of a prior biliary sphincterotomy.\n3. Ability to receive rectal medication.\n4. Ability and willingness to comply with all study procedures and follow-up requirements.\n5. Written informed consent (and assent when applicable) was obtained from the subject or the subject's legal representative, and the subject's ability to comply with the requirements of the study was confirmed.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n2. Known hypersensitivity or contraindication to indomethacin, other nonsteroidal anti-inflammatory drugs, or suppository components.\n3. Active gastrointestinal bleeding, history of NSAID-induced gastrointestinal ulceration, or other conditions that contraindicate NSAID use.\n4. Significant renal impairment (e.g., baseline serum creatinine above institutional upper limit of normal or estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n5. Current use of other NSAIDs that cannot be safely discontinued per the investigator's judgment.\n6. Known chronic pancreatitis\n7. Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.","ALL","18 Years",{"count":19,"type":20},860,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study is a randomized clinical trial evaluating the efficacy of rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients undergoing biliary ERCP who have a history of prior biliary sphincterotomy. While rectal indomethacin has demonstrated benefits in preventing post-ERCP pancreatitis in high-risk patients, its utility in this specific patient subgroup remains unclear. This trial aims to determine whether prophylactic administration of indomethacin offers a measurable benefit over no intervention in this lower-risk population.\n\nEligible patients will be identified prior to their scheduled biliary ERCP and screened for inclusion criteria. Following informed consent, participants will be randomized to receive either rectal indomethacin or no indomethacin prior to the procedure.",[26,27,28,29,30,31],"Pancreatitis Biliary","Pancreatitis Acute Biliary","Pancreatitis","Post-ERCP Pancreatitis","Post-ERCP Acute Pancreatitis","Post-ERCP Adverse Events",[33,34,35,36,37,38],"ERCP","pancreatitis","post-ERCP pancreatitis","PEP","pancreatitis acute biliary","post-ERCP adverse events","NOT_YET_RECRUITING","2026-06-16",{"date":42,"type":43},"2026-06-22","ACTUAL",{"date":45,"type":20},"2026-07",{"date":47,"type":20},"2031-07",{"name":49,"class":50},"University of California, San Francisco","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":51},"100536134","phase-4-short-term-intravenous-fluids-for-prevention-of-post-ercp-pancreatitis-100536134","NCT06260878","Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis","STRIPE","Inclusion Criteria:\n\n1. age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients \\>75 years of age)\n2. ability to give informed consent\n3. native major papillary anatomy\n4. ability and willingness to obtain bloodwork the day after ERCP\n\nExclusion Criteria:\n\n1. prior ERCP with sphincterotomy and\u002For sphincteroplasty\n2. confirmed or suspected cholangitis or sepsis\n3. confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days\n4. NYHA Class II or greater heart failure\n5. active pulmonary edema\n6. myocardial infarction or ischemia within the preceding 3 months\n7. renal insufficiency with CrCl \\\u003C 40 mL\u002Fminute\n8. CPT Class B or C cirrhosis and\u002For end-stage liver disease\n9. room air oxygen saturation \\\u003C90% or requirement of home O2\n10. hypernatremia with Na+ ≥ 150 mEq\u002FL or Na+ \\\u003C130 mEq\u002FL\n11. uncontrolled hypertension or hypotension\n12. pregnant status",true,"75 Years",{"count":62,"type":20},505,[23],"This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.",[30],"RECRUITING","2026-04-28",{"date":69,"type":43},"2026-04-29",{"date":71,"type":43},"2024-11-22",{"date":73,"type":20},"2028-12-31",{"name":75,"class":50},"University of Calgary",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100458679","phase-3-rectal-indomethacin-and-oral-tacrolimus-versus-combination-to-prevent-post-ercp-pancreatitis-100458679","NCT05252754","Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis","A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis","INTRO","Inclusion Criteria:\n\n* Any patient who is undergoing endoscopic retrograde cholangiopancreatography (ERCP) at any of the participating centers, is at least 18 years old and provides informed consent can be included in the study.\n\nExclusion Criteria:\n\n* Unwillingness or inability to consent for the study.\n* Pregnancy\n* Breastfeeding mother\n* Chronic calcific pancreatitis\n* ERCP for biliary stent exchange or removal\n* ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram.\n* Biliary intervention in a patient with pancreas divisum.\n* Standard contraindications to tacrolimus or NSAID use.\n* Current tacrolimus or immune modulator use.\n* Chronic kidney disease with glomerular filtration rate (GFR) \\\u003C 30 or acute kidney injury.\n* Absence of rectum.\n* Acute pancreatitis within 30 days of ERCP.\n* Pancreatic head malignancy.\n* Sphincter of Oddi dysfunction (Type 3).",{"count":85,"type":20},4874,[87],"PHASE3","This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).",[30],"2025-12-05",{"date":92,"type":43},"2025-12-09",{"date":94,"type":43},"2023-01-18",{"date":96,"type":20},"2026-12",{"name":98,"class":50},"Johns Hopkins University",5,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100601962","rectal-nsaids-withwithout-pd-stent-for-pep-prevention-100601962","NCT07117318","Rectal NSAIDs With\u002FWithout PD Stent for PEP Prevention","Rectal Non-steroid Anti-inflammatory Drugs With or Without Prophylactic Pancreatic Duct Stent for Prevention of Post-ERCP Pancreatitis: a Multicenter, Randomized, Non-inferiority Trial","Inclusion Criteria:\n\n* 18-90 years old patients with native papilla who planned to undergo ERCP\n* high-risk patients for post-ERCP pancreatitis must meet one or more following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation (\\>5 cannulation attempts, or \\>5mins cannulation time, or \\>1 unintentional pancreatic duct cannulation), or ballon dilatation of an intact biliary sphincter ≤ 1 min, double-wire cannulation. Additionally, patients were considered high-risk if they fulfilled two or more of the following minor criteria: female gender under 50 years old, a history of recurrent pancreatitis (two or more episodes), three or more contrast injections into the pancreatic duct with at least one injection reaching the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct.\n\nExclusion Criteria:\n\n* Previous biliary sphincterotomy and papillary large balloon dilation\n* Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy)\n* Allergy to NSAIDs\n* The administration of NSAIDs within 7 days\n* Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \\[Cr \\>1.4mg\u002Fdl=120umol\u002Fl\\]; presence of coagulopathy before the procedure)\n* Acute pancreatitis within 7 days before ERCP or acute pancreatitis with obvious Pancreatic edema and peripancreatic fluid collections\n* Hemodynamical instability\n* Pregnancy or lactation\n* high-risk patients with pancreatic duct wire passages","90 Years",{"count":109,"type":20},1278,[111],"NA","Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stent (PDS) placement were demonstrated to be effective strategyies to reduce PEP incidences, particlularly in high-risk patients for post-ERCP pancreatitis (PEP).\n\nRectal NSAIDs were easy-to-use and safe, while PDS placement were technically complex and carried higher risks of adverse events. A previous network meta-analysis suggested rectal NSAIDs in combination with PDS placement did not differ from rectal NSAIDs alone in PEP prevention. To invesigate if rectal NSAIDs alone could obivate the need of PDS placement, a recent trial from Elmunzer et al. conducted a randomized trial to investigate if rectal NSAIDs alone was non-inferior to the combination of NSAIDs with PDS in high-risk patients. The trial found that the PEP incidence rate in combination group was significantly lower than that in NSAIDs alone group. However, post-hoc analysis of the study suggested that the combination strategy conferred significant benefits only in high-risk patients with pancreatic duct (PD) wire passage, but not in those with other risk factors. Therefore, we hypothesized that rectal NSAIDs alone may obivate the need of PDS in high-risk patients without PD wire passages. Here, we conducted a multicenter, randomized and non-inferiority trial to investigate whether rectal NSAIDs alone is non-inferior to NSAIDs plus PDS placement in high-risk patients without PD wire passages.",[30,114,115],"Non-steroid Anti-inflammatory Drugs","Pancreatic Duct Stent Placement","2025-12-01",{"date":118,"type":43},"2025-12-03",{"date":120,"type":43},"2025-07-01",{"date":122,"type":20},"2028-06-01",{"name":124,"class":50},"Air Force Military Medical University, China",15,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":51},"100459804","an-european-multi-centre-cohort-study-for-unravelling-pharmacokinetic-and-genetic-factors-underlying-post-ercp-pancreatitis-100459804","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.",{"count":134,"type":20},700,"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.",[30],"2025-04-18",{"date":140,"type":43},"2025-04-23",{"date":142,"type":43},"2022-03-01",{"date":144,"type":20},"2027-12-01",{"name":146,"class":50},"Radboud University Medical Center",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100302340","lactated-ringers-solution-to-prevent-post-ercp-pancreatitis-100302340","NCT03215862","Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis","The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis","Inclusion Criteria:\n\ni. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and\u002For if patient is to undergo a planned endoscopic intervention deemed at high risk:\n\n1. Suspicion of Oddi dysfunction\n2. Personal history of post-ERCP pancreatitis\n3. More than 8 cannulation attempts\n4. Precut sphincterotomy\n5. Endoscopic papillary balloon dilation of an intact sphincter\n6. Endoscopic pancreatic duct sphincterotomy\n7. Ampullectomy\n8. Total bilirubin \\\u003C 1.0\n\nii. Or possession of two or more of the following minor criteria:\n\n1. Female sex\n2. Age under 50 years\n3. Personal history of recurrent acute pancreatitis\n4. Pancreatic duct injection leading to \"acinarization\" or over 3 pancreatic duct injections\n5. Pancreatic duct cytology acquisition\n\nExclusion Criteria:\n\n1. Patients aged less than 18\n2. Inability to provide informed consent\n3. Pregnancy\n4. Active acute pancreatitis\n5. Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation \\\u003C 90% on room air), chronic kidney disease (creatinine clearance \\\u003C 40 mL\u002Fmin), systolic congestive heart failure (ejection fraction \\\u003C 45%), cirrhosis, and severe electrolyte disturbance with sodium \\\u003C130 mEq\u002FL or \\>150 mEq\u002FL\n6. If patient does not undergo a planned high-risk intervention\n7. If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis\n8. Patients with cholangitis\n9. Patients with chronic and\u002For active pancreatitis\n10. Patients with a true NSAID allergy\n11. Patients greater than or equal to 75 years old","74 Years",{"count":156,"type":20},242,[111],"This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.",[30],[30,161,162],"Normal Saline","Lactated Ringer's","2017-07-10",{"date":165,"type":43},"2017-07-12",{"date":167,"type":20},"2017-08-01",{"date":169,"type":20},"2018-08-01",{"name":171,"class":50},"University of South Florida"]