Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Outpatient Versus Inpatient Management of Mild Acute Pancreatitis

9. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tunisia
    • Tunisia
      • Ben Arous, Tunisia, Tunisia, 2074
        • Traumatology and great burns center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Aktiv komparator: 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.
Annen: Standard Inpatient Management (Group B)
Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Treatment Failure Rate at 30 Days
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recurrence of abdominal pain Assessed by Numeric Rating Scale (NRS)
Tidsramme: 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
Tidsramme: 48 hours
48 hours
Organ failure Assessed by the Modified Marshall Scoring System
Tidsramme: 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
Tidsramme: 30 days
30 days
ICU admission rate
Tidsramme: 30 days
30 days
Patient satisfaction Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Center for Traumatology and Major Burns, Ben Arous

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

28. februar 2027

Studiet fullført (Antatt)

31. mars 2027

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CTGBA/EC/2025/07-03

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere