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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.
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.
This 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/APA-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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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/APA-compliant supportive care. |
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| 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/APA guidelines. Discharge is determined by clinical improvement and full oral diet tolerance. A 30-day follow-up consultation is arranged at discharge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient Management (Group A) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure Rate at 30 Days | Proportion of patients experiencing at least one of the following: food intolerance (<50% 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ≥4/10 after an initial pain-free interval following discharge or hospital admission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imen Ben Ismail, M.D | Contact | +21696121434 | imen.benismail@fmt.utm.tn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Traumatology and great burns center | Ben Arous | Tunisia | 2074 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32233793 | Result | Nardiello C, Morty RE. World No Tobacco Day 2020. Am J Physiol Lung Cell Mol Physiol. 2020 May 1;318(5):L1010-L1015. doi: 10.1152/ajplung.00110.2020. Epub 2020 Apr 1. No abstract available. | |
| 24054878 | Result | Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Standard Inpatient Management (Group B) | Other | Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement. |
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| 30 days |
| SIRS score at 48 hours | 48 hours |
| 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/FiO₂ 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. | 30 days |
| Unplanned hospital readmission | 30 days |
| ICU admission rate | 30 days |
| 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. | 30 days |
| 19245846 | Result | Lankisch PG, Weber-Dany B, Hebel K, Maisonneuve P, Lowenfels AB. The harmless acute pancreatitis score: a clinical algorithm for rapid initial stratification of nonsevere disease. Clin Gastroenterol Hepatol. 2009 Jun;7(6):702-5; quiz 607. doi: 10.1016/j.cgh.2009.02.020. Epub 2009 Feb 24. |
| 23100216 | Result | Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25. |