[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656424":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":67,"studyPopulation":55,"armGroups":68,"interventions":81,"overallOfficials":55,"centralContacts":55,"locations":55,"responsibleParty":94,"collaborators":55,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":55,"enrollmentInfo":108,"targetDuration":55,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":122,"whyStopped":55,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":55},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Post-ERCP Pancreatitis","Post-ERCP pancreatitis will be defined as new abdominal pain after ERCP with serum amylase or lipase at least three times the upper limit of normal.","Within 24 hours after ERCP",[14,17,20,23,27,30,33,36,39,42,45,48,51],{"measure":15,"description":16,"timeFrame":12},"Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation","Incidence of post-ERCP pancreatitis among participants meeting the protocol-defined criteria for difficult cannulation.",{"measure":18,"description":19,"timeFrame":12},"Incidence of Post-ERCP Pancreatitis in Participants With Pancreatic Duct Cannulation","Incidence of post-ERCP pancreatitis among participants in whom the pancreatic duct is cannulated during ERCP.",{"measure":21,"description":22,"timeFrame":12},"Incidence of Post-ERCP Pancreatitis in Participants With High-Risk Features","Incidence of post-ERCP pancreatitis among participants with protocol-defined high-risk features for PEP.",{"measure":24,"description":25,"timeFrame":26},"Severity of Post-ERCP Pancreatitis","Severity will be classified according to the Revised Atlanta Classification as mild, moderately severe, or severe acute pancreatitis.","Up to 30 days after ERCP",{"measure":28,"description":29,"timeFrame":12},"Post-ERCP Hyperamylasemia and\u002For Hyperlipasemia Without Pancreatitis","Proportion of participants with elevated serum amylase and\u002For lipase after ERCP without meeting criteria for post-ERCP pancreatitis.",{"measure":31,"description":32,"timeFrame":26},"Bleeding","Incidence of ERCP-related bleeding.",{"measure":34,"description":35,"timeFrame":26},"Cholangitis","Incidence of cholangitis following ERCP.",{"measure":37,"description":38,"timeFrame":26},"Perforation","Incidence of ERCP-related perforation.",{"measure":40,"description":41,"timeFrame":26},"Mortality","All-cause mortality during study follow-up.",{"measure":43,"description":44,"timeFrame":26},"ICU Admission","Proportion of participants requiring admission to an intensive care unit.",{"measure":46,"description":47,"timeFrame":26},"Hospital Admission or Prolonged Hospitalization","Proportion of participants requiring hospital admission or prolonged hospitalization following ERCP.",{"measure":49,"description":50,"timeFrame":26},"Need for Rescue Interventions","Proportion of participants requiring additional rescue interventions for an ERCP-related complication.",{"measure":52,"description":53,"timeFrame":54},"30-Day Readmission","Proportion of participants readmitted to hospital within 30 days following ERCP.","Within 30 days after ERCP",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","Two-arm, parallel-group superiority trial with participants randomized in a 1:1 ratio to rectal indomethacin alone or rectal indomethacin plus post-procedural papillary ice water irrigation.","PREVENTION",{"masking":62,"maskingDescription":63,"whoMasked":64},"DOUBLE","Participants and outcome assessors will remain blinded to treatment allocation. Data analysts will also remain blinded. The endoscopist performing the ERCP cannot be blinded because they must either perform or omit post-procedural papillary ice water irrigation. Procedural documentation available to blinded outcome assessors will use neutral or standardized language where feasible to minimize inadvertent unblinding.",[65,66],"PARTICIPANT","OUTCOMES_ASSESSOR","The N-ICE Trial is a prospective, randomized, patient- and assessor-blinded, parallel-group superiority trial evaluating whether post-procedural papillary ice water irrigation provides additional protection against post-ERCP pancreatitis (PEP) when added to standard rectal indomethacin prophylaxis.\n\nEligible adults undergoing ERCP with a native papilla will be randomized in a 1:1 ratio to receive either rectal indomethacin 100 mg alone or rectal indomethacin 100 mg plus post-procedural papillary ice water irrigation. In the intervention group, immediately following completion of ERCP and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots under direct endoscopic visualization. The endoscopist cannot be blinded to treatment assignment; participants and outcome assessors will remain blinded.\n\nThe primary objective is to determine whether adding papillary ice water irrigation to rectal indomethacin reduces the incidence of PEP. Participants will undergo clinical and biochemical assessment following ERCP, including measurement of serum amylase and\u002For lipase within 24 hours, with subsequent follow-up for delayed adverse events and health care utilization through 30 days.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Rectal Indomethacin Alone","ACTIVE_COMPARATOR","Participants will receive rectal indomethacin 100 mg administered peri-procedurally according to standard institutional practice. No post-procedural papillary ice water irrigation will be performed.",[74],"Drug: Rectal Indomethacin",{"label":76,"type":77,"description":78,"interventionNames":79},"Rectal Indomethacin Plus Papillary Ice Water Irrigation","EXPERIMENTAL","Participants will receive rectal indomethacin 100 mg administered peri-procedurally. Immediately after completion of ERCP, while the participant remains sedated and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots under direct endoscopic visualization.",[74,80],"Procedure: Papillary Ice Water Irrigation",[82,89],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"DRUG","Rectal Indomethacin","Rectal indomethacin 100 mg administered peri-procedurally for prevention of post-ERCP pancreatitis according to institutional practice.",[70,76],[88],"Indomethacin",{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":55},"PROCEDURE","Papillary Ice Water Irrigation","Immediately after completion of ERCP and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots through the endoscope working channel under direct endoscopic visualization. The intervention is expected to add approximately 2 minutes to the procedure.",[76],{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"PRINCIPAL_INVESTIGATOR","Sunil Gupta","Assistant Professor","100656424","rectal-indomethacin-with-or-without-papillary-ice-water-irrigation-to-prevent-post-ercp-pancreatitis-100656424",false,"NCT07826026","Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis","Rectal Indomethacin Alone Versus Rectal Indomethacin Plus Post-procedural Papillary Ice Water Irrigation for Prevention of Post-ERCP Pancreatitis (N-ICE Trial): A Randomized, Patient- and Assessor-Blinded, Superiority Multicenter Trial","N-ICE","Inclusion Criteria:\n\n* Age 18 years or older.\n* Undergoing ERCP with a native papilla.\n* Eligible to receive rectal indomethacin.\n* Able to provide informed consent.\n* Willing and able to complete the required follow-up and post-procedure bloodwork.\n\nExclusion Criteria:\n\n* Known allergy, hypersensitivity, or contraindication to indomethacin or rectal NSAIDs.\n* Active acute pancreatitis at the time of ERCP.\n* Prior sphincterotomy or absent native papilla.\n* Prediction of papilla inaccessibility.\n* Pregnancy.\n* Inability or unwillingness to provide informed consent.\n* Any clinical circumstance in which the treating endoscopist judges study participation to be unsafe or inappropriate.\n* Chronic pancreatitis.\n* Pancreatic head malignancy with complete main pancreatic duct obstruction.\n* Altered luminal anatomy, other than Billroth I.","ALL","18 Years",{"count":109,"type":110},120,"ESTIMATED","INTERVENTIONAL",[113],"NA","Post-endoscopic retrograde cholangiopancreatography pancreatitis (post-ERCP pancreatitis, or PEP) is inflammation of the pancreas that can occur after an ERCP procedure. Rectal indomethacin is commonly given around the time of ERCP to help reduce this risk, but pancreatitis can still occur despite this treatment.\n\nThe purpose of this randomized clinical trial is to determine whether adding ice water irrigation of the papilla at the end of ERCP further reduces the risk of post-ERCP pancreatitis compared with rectal indomethacin alone. The papilla is the small opening in the intestine where the bile duct and pancreatic duct drain.\n\nParticipants will be randomly assigned to one of two groups. Both groups will receive rectal indomethacin 100 mg. In the intervention group, the doctor will also irrigate the papilla with a total of 250 mL of ice water immediately after the ERCP. Participants and the study team members who assess study outcomes will not know which treatment group the participant was assigned to. Participants will be assessed after ERCP and followed for up to 30 days for pancreatitis and other complications.",[116],"Pancreatitis",[118,119,120,121],"Post-ERCP pancreatitis","Endoscopic retrograde cholangiopancreatography","Rectal indomethacin","Papillary cryoprevention","NOT_YET_RECRUITING","2026-09-18",{"date":125,"type":126},"2026-09-21","ACTUAL",{"date":128,"type":110},"2026-10-01",{"date":130,"type":110},"2030-12-01",{"name":5,"class":6}]