[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641977":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":40,"studyPopulation":20,"armGroups":41,"interventions":54,"overallOfficials":20,"centralContacts":61,"locations":67,"responsibleParty":84,"collaborators":20,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":20,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":20,"enrollmentInfo":96,"targetDuration":20,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":114,"whyStopped":20,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Center for Traumatology and Major Burns, Ben Arous","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment Failure Rate at 30 Days","Proportion of patients experiencing at least one of the following: food intolerance (\\\u003C50% of a standard meal), persistent nausea or vomiting refractory to antiemetics, uncontrolled pain requiring parenteral analgesia or emergency attendance, new-onset SIRS or HAPS deterioration, or (Group A only) any unplanned hospital admission.","30 days from randomisation",[14,18,22,25,27,29],{"measure":15,"description":16,"timeFrame":17},"Recurrence of abdominal pain Assessed by Numeric Rating Scale (NRS)","Recurrence of abdominal pain during the 30-day follow-up period, assessed at each contact point (teleconsultation Days 1, 2, 3; clinic visit Day 4; final visit Day 30) using the Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst imaginable pain). Recurrence is defined as any new episode of abdominal pain scoring ≥4\u002F10 after an initial pain-free interval following discharge or hospital admission.","30 days",{"measure":19,"description":20,"timeFrame":21},"SIRS score at 48 hours",null,"48 hours",{"measure":23,"description":24,"timeFrame":17},"Organ failure Assessed by the Modified Marshall Scoring System","Rate of organ failure occurring within 30 days of randomisation, assessed using the Modified Marshall Scoring System. Organ failure is defined as a score of ≥2 in any of the three organ systems evaluated: respiratory (PaO₂\u002FFiO₂ ratio), renal (serum creatinine), and cardiovascular (systolic blood pressure). Transient organ failure (resolving within 48 hours) and persistent organ failure (lasting \\>48 hours) will be recorded separately.",{"measure":26,"description":20,"timeFrame":17},"Unplanned hospital readmission",{"measure":28,"description":20,"timeFrame":17},"ICU admission rate",{"measure":30,"description":31,"timeFrame":17},"Patient satisfaction Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)","Patient satisfaction with the allocated management strategy, assessed at the 30-day follow-up visit using the Patient Satisfaction Questionnaire Short Form (PSQ-18), a validated 18-item instrument evaluating satisfaction across seven domains: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility. Each item is rated on a 5-point Likert scale (1 = strongly agree to 5 = strongly disagree). Domain scores are transformed to a 0-100 scale, with higher scores indicating greater satisfaction.",{"allocation":33,"interventionModel":34,"interventionModelDescription":20,"primaryPurpose":35,"observationalModel":20,"timePerspective":20,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":20,"whoMasked":38},"SINGLE",[39],"OUTCOMES_ASSESSOR","Acute pancreatitis (AP) is one of the most common gastrointestinal causes of emergency hospital admission worldwide. Approximately 80% of cases are classified as mild according to the revised Atlanta Classification (2012) and resolve without organ failure or local complications within three to five days. Despite this favorable prognosis, current practice mandates universal inpatient admission. Only two small studies have explored outpatient management of mild AP, reporting treatment failure rates of 4-12% in the ambulatory arm; however, neither was prospectively randomized nor adequately powered for non-inferiority.\n\nThis trial is a prospective, single-center, open-label, two-arm, parallel-group, randomized controlled non-inferiority trial. Patients presenting with mild AP, confirmed by at least two revised Atlanta (2012) criteria and classified as mild by a SIRS score of 0 and a Harmless Acute Pancreatitis Score (HAPS) of 0, will be randomly allocated in a 1:1 ratio to outpatient management (Group A) or standard inpatient care (Group B). Randomization will use a table of random numbers with a block size of four. Group A patients will receive an initial 4-6 hour supervised observation period in the emergency department, followed by daily teleconsultation on days 1-3 and an in-person clinic visit on day 4. Group B patients will be admitted to hospital per standard institutional protocol. All patients will receive IAP\u002FAPA-compliant supportive care and a final 30-day outcome assessment. The primary endpoint is the 30-day treatment failure rate. Non-inferiority will be declared if the upper bound of the one-sided 95% confidence interval for the between-group difference does not exceed 10%.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"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.",[47],"Other: Outpatient Management (Group A)",{"label":49,"type":50,"description":51,"interventionNames":52},"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.",[53],"Other: Standard Inpatient Management (Group B)",[55,58],{"type":6,"name":43,"description":56,"armGroupLabels":57,"otherNames":20},"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.",[43],{"type":6,"name":49,"description":59,"armGroupLabels":60,"otherNames":20},"Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement.",[49],[62],{"name":63,"role":64,"phone":65,"phoneExt":20,"email":66},"Imen Ben Ismail, M.D","CONTACT","+21696121434","imen.benismail@fmt.utm.tn",[68],{"facility":69,"status":20,"city":70,"state":71,"zip":72,"country":71,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Traumatology and great burns center","Ben Arous","Tunisia","2074","TN",{"type":75,"coordinates":76},"Point",[77,78],10.22167,36.75452,{"lat":78,"lon":77},[81],{"name":82,"role":64,"phone":83,"phoneExt":20,"email":66},"Imen Ben Ismail","26196121434",{"type":85,"investigatorFullName":82,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"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":97,"type":98},150,"ESTIMATED","INTERVENTIONAL",[101],"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.",[104,105],"Acute Pancreatitis (AP)","Biliary Pancreatitis",[107,108,109,110,111,112,113],"acute pancreatitis","outpatient","ambulatory","non-inferiority","randomised controlled trial","HAPS","SIRS","NOT_YET_RECRUITING","2026-07-09",{"date":117,"type":118},"2026-07-10","ACTUAL",{"date":120,"type":98},"2026-07-01",{"date":122,"type":98},"2027-03-31",{"name":5,"class":6},1]