[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641977":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":81,"whyStopped":24,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Center for Traumatology and Major Burns, Ben Arous","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Outpatient Management (Group A)","EXPERIMENTAL","Patients receive a 4-6 hour supervised observation in the emergency department, then are discharged with structured ambulatory follow-up: daily teleconsultation on Days 1, 2, and 3; in-person clinic visit with blood sampling on Day 4; open-access emergency readmission at any time; and a 30-day final consultation. All patients receive IAP\u002FAPA-compliant supportive care.",[13],"Other: Outpatient Management (Group A)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Inpatient Management (Group B)","ACTIVE_COMPARATOR","Patients are admitted to the gastroenterology or surgical ward for conventional inpatient care with daily clinical and biological monitoring, intravenous fluids, analgesia, antiemetics, and early oral refeeding per IAP\u002FAPA guidelines. Discharge is determined by clinical improvement and full oral diet tolerance. A 30-day follow-up consultation is arranged at discharge.",[19],"Other: Standard Inpatient Management (Group B)",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Early discharge from the emergency department after 4-6 hours of observation, with structured teleconsultation follow-up on Days 1, 2, and 3, in-person review on Day 4, unrestricted emergency department access, and 30-day outcome assessment.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Imen Ben Ismail, M.D","CONTACT","+21696121434","imen.benismail@fmt.utm.tn",[35],{"facility":36,"status":24,"city":37,"state":38,"zip":39,"country":38,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Traumatology and great burns center","Ben Arous","Tunisia","2074","TN",{"type":42,"coordinates":43},"Point",[44,45],10.22167,36.75452,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":50,"phoneExt":24,"email":33},"Imen Ben Ismail","26196121434",{"type":52,"investigatorFullName":49,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Associate professor in visceral and digestive surgery","100641977","outpatient-versus-inpatient-management-of-mild-acute-pancreatitis-100641977",false,"NCT07643961","Outpatient Versus Inpatient Management of Mild Acute Pancreatitis","Outpatient Versus Inpatient Management of Mild Acute Pancreatitis: A Randomised Controlled Non-Inferiority Trial","Inclusion Criteria:\n\n* Age 18 years or older Diagnosis of acute pancreatitis based on at least two of three revised Atlanta (2012) criteria: characteristic abdominal pain; serum lipase or amylase ≥3× upper limit of normal; or characteristic imaging findings Classification as mild acute pancreatitis: SIRS score = 0 and HAPS score = 0 at emergency department presentation Ability to tolerate oral intake at the time of randomisation Provision of written informed consent Presence of a competent caregiver at home Residence within 30-45 minutes' travel time from the hospital Ability to communicate by telephone\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding Inability to maintain oral intake for reasons unrelated to acute pancreatitis Acute pancreatitis attributable to tumour, post-ERCP intervention, or abdominal trauma Concurrent choledocholithiasis with or without cholangitis Chronic pancreatitis or history of recurrent acute pancreatitis (≥2 prior episodes) ASA physical status classification ≥ 3 Clinical or radiological features suggesting moderately severe or severe acute pancreatitis Alcohol withdrawal syndrome No competent caregiver at home Residence more than 30-45 minutes from the hospital Inability to communicate by telephone or equivalent means","ALL","18 Years",{"count":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"NA","Acute pancreatitis is a sudden inflammation of the pancreas that causes severe abdominal pain. Most cases are mild and get better within a few days with basic supportive treatment such as fluids and pain relief. Currently, all patients with acute pancreatitis are admitted to hospital, even those with a very low risk of complications. This study will test whether patients with mild acute pancreatitis can be safely sent home with close follow-up (telephone calls on days 1, 2, and 3 after discharge and a clinic visit on day 4) instead of staying in hospital. Patients will be randomly assigned to either home management or standard hospitalization. We will compare the rate of treatment failure at 30 days between the two groups. We expect that home management will be as safe as hospitalization, while being more convenient for patients and less costly for the health system.",[71,72],"Acute Pancreatitis (AP)","Biliary Pancreatitis",[74,75,76,77,78,79,80],"acute pancreatitis","outpatient","ambulatory","non-inferiority","randomised controlled trial","HAPS","SIRS","NOT_YET_RECRUITING","2026-06-10",{"date":84,"type":85},"2026-06-12","ACTUAL",{"date":87,"type":65},"2026-07-01",{"date":89,"type":65},"2027-03-31",{"name":5,"class":6},1]