[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634087":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":16,"overallOfficials":35,"centralContacts":39,"locations":16,"responsibleParty":44,"collaborators":16,"id":46,"slug":16,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":16,"enrollmentInfo":55,"targetDuration":16,"studyType":58,"phases":16,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":66,"whyStopped":16,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":16},{"fullName":5,"class":6},"A.O.U. Città della Salute e della Scienza","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Association between clinically relevant PEI and IPMN progression during follow-up","Clinically relevant PEI defined as:\n\n* FE-1 \\\u003C100 µg\u002Fg OR\n* FE-1 100-200 µg\u002Fg plus ≥1 clinical criterion IPMN progression defined by WF\u002FHRS development, surgical referral, or histologic progression","Day 1 and after 6 and 12 months",[14,17,19,21,24],{"measure":15,"description":16,"timeFrame":12},"Prevalence and incidence of PEI in IPMN patients",null,{"measure":18,"description":16,"timeFrame":12},"Association between imaging parameters (MPD diameter, parenchymal atrophy) and PEI",{"measure":20,"description":16,"timeFrame":12},"Time-to-progression stratified by PEI status",{"measure":22,"description":23,"timeFrame":12},"Nutritional impact of PEI","Weight loss",{"measure":25,"description":16,"timeFrame":12},"Incremental predictive value of PEI beyond imaging criteria",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":27,"timePerspective":28,"maskingInfo":16},"COHORT","PROSPECTIVE","progression in patients diagnosed with branch-duct, main-duct, or mixed-type IPMN undergoing routine surveillance.\n\nPEI will be assessed using a composite clinical-biochemical definition based on fecal elastase-1 (FE-1) levels and standardized clinical evaluation through a pancreatology visit and PEI Symptom Score (PSS).\n\nIPMN progression will be defined according to the development of worrisome features (WF), high-risk stigmata (HRS), need for intensified surveillance, referral to surgery, histologic high-grade dysplasia\u002Fcarcinoma, or diagnosis of concomitant pancreatic ductal adenocarcinoma.\n\nThe study does not introduce any intervention beyond standard care and aims to determine whether PEI represents a marker of functional pancreatic deterioration associated with IPMN evolution.","Patients undergoing routine surveillance for IPMN at participating centers.",[32],{"label":33,"type":16,"description":34,"interventionNames":16},"IPMN","This study includes a single prospective observational cohort of adult patients (≥18 years) with a diagnosis of intraductal papillary mucinous neoplasm (IPMN)-including branch-duct, main-duct, or mixed-type.\n\nParticipants are managed according to standard-of-care IPMN surveillance protocols (MRI\u002FMRCP ± EUS), with no mandated interventional treatment. In parallel, patients undergo a structured pancreatology assessment to evaluate pancreatic exocrine function.\n\nThe exposure of interest is pancreatic exocrine insufficiency (PEI), defined using a composite clinical-biochemical criterion based on fecal elastase-1 (FE-1) levels and standardized clinical and nutritional parameters. No experimental intervention is administered; initiation of pancreatic enzyme replacement therapy (PERT), when clinically indicated, is recorded but not protocol-driven.",[36],{"name":37,"affiliation":5,"role":38},"Giacomo Deiro, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":16,"email":43},"CONTACT","+393489818794","giacomo.deiro@gmail.com",{"type":45,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100634087",false,"NCT07535125","IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN","IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN Under Surveillance","IPEX","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN\n* Under active imaging surveillance\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior pancreatic surgery\n* Chronic pancreatitis\n* Known pancreatic ductal adenocarcinoma at baseline\n* Other established causes of PEI unrelated to IPMN","ALL","18 Years",{"count":56,"type":57},600,"ESTIMATED","OBSERVATIONAL","Intraductal Papillary Mucinous Neoplasms (IPMN) are pancreatic cystic neoplasms managed through imaging-based surveillance focused on oncologic risk. However, IPMN pathophysiology includes ductal obstruction by mucin, chronic ductal hypertension, and progressive parenchymal atrophy, mechanisms that may lead to pancreatic exocrine insufficiency (PEI).\n\nPEI is a maldigestion syndrome typically associated with chronic pancreatitis, pancreatic cancer, and pancreatic surgery, but it has never been systematically investigated in patients with IPMN under surveillance.\n\nThe IPEX study is a multicenter prospective observational cohort study designed to evaluate whether PEI is prevalent in IPMN patients and whether it correlates with morphologic disease progression. The study also evaluates the potential role of PEI as a functional marker complementary to imaging criteria in IPMN surveillance.",[61,62],"Intraductal Papillary Mucinous Neoplasms","Pancreatic Exocrine Insufficiency",[64,65,61],"Functional Marker","pancreatic exocrine insufficiency","NOT_YET_RECRUITING","2026-04-09",{"date":69,"type":70},"2026-04-16","ACTUAL",{"date":72,"type":57},"2026-07-01",{"date":74,"type":57},"2027-12-31",{"name":5,"class":6}]