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Outpatient Versus Inpatient Management of Mild Acute Pancreatitis

9 juli 2026 bijgewerkt door: Imen Ben Ismail, Center for Traumatology and Major Burns, Ben Arous

Outpatient Versus Inpatient Management of Mild Acute Pancreatitis: A Randomised Controlled Non-Inferiority Trial

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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%.

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Tunesië
    • Tunisia
      • Ben Arous, Tunisia, Tunesië, 2074

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Outpatient Management (Group A)
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.
Ander: Outpatient Management (Group A)
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.
Actieve vergelijker: Standard Inpatient Management (Group B)
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.
Ander: Standard Inpatient Management (Group B)
Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment Failure Rate at 30 Days
Tijdsspanne: 30 days from randomisation
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recurrence of abdominal pain Assessed by Numeric Rating Scale (NRS)
Tijdsspanne: 30 days
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.
30 days
SIRS score at 48 hours
Tijdsspanne: 48 hours
48 hours
Organ failure Assessed by the Modified Marshall Scoring System
Tijdsspanne: 30 days
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
Tijdsspanne: 30 days
30 days
ICU admission rate
Tijdsspanne: 30 days
30 days
Patient satisfaction Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Tijdsspanne: 30 days
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Center for Traumatology and Major Burns, Ben Arous

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

28 februari 2027

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

8 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CTGBA/EC/2025/07-03

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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