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Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

Non Recruiting
18-80 years
All
Phase N/A

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Overview

Acute pancreatitis accounts for a large number of hospital admissions every year. Some studies have shown that early oral feeding protocols are safe, and one previous study suggests the possibility of home care for mild acute pancreatitis.

Description

Approximately 80% of all cases of acute pancreatitis are mild and only require supportive care for pain and nausea control and an adequate fluid replacement. Currently, all patients in our setting diagnosed with mild acute pancreatitis are admitted to a conventional hospitalization ward under the supervision of the Digestive and General Surgery Department or the Gastroenterology Department. Symptomatic treatment is administered, and abdominal ultrasound is performed to assess the cause of pancreatic inflammation. The remaining 20% fulfill the severity criteria from its onset onwards and require intensive care support.

We will conduct a multicenter randomized controlled clinical trial to compare two different approaches to mild non-alcoholic acute pancreatitis: hospital admission and outpatient management.

Eligibility

INCLUSION CRITERIA

        Patients diagnosed with mild acute pancreatitis based on at least two of the three
        following criteria:
          -  Abdominal pain
          -  Amylase or lipase 3x ULN (in blood/urine)
          -  Imaging tests (Ultrasound/CT scan) suggestive of acute pancreatitis.
        Age ≥18 years and <80 years
        Absence of potential pancreatitis-related severity criteria:
          -  No evidence of SIRS in the emergency room
          -  C-Reactive Protein levels <150mg/dL
          -  Marked increase in the White Blood Cell Count
          -  Absence of coagulopathy (INR <1.4)
          -  Hematocrit < 44%
          -  Creatinine < 170 µmol/L
          -  BISAP score ≤2 at the time of randomization.
        Patients with good pain response to 12-hour supportive care in the ER (VAS <4) or adequate
        oral feeding tolerability.
        Absence of local or systemic complications of acute pancreatitis on imaging tests.
        Adequate cognitive capacity and without any previous diagnose of psychiatric disease.
        Patients who meet each participating hospital home care criteria. Patients who give their
        written informed consent to participate.
        EXCLUSION CRITERIA
        Past medical history of pancreatic disease:
          -  Known or newly diagnosed chronic pancreatitis (Wirsung dilation or pancreatic
             calcifications in previous imaging tests)
          -  Patients with recurrent acute pancreatitis (>3 episodes/year) or an episode of acute
             pancreatitis <1 month ago.
          -  Acute pancreatitis after endoscopic retrograde cholangiography.
          -  Hyperbilirubinemia >3x ULN
        Comorbidities that required previous hospitalization (myocardial infarction, liver
        cirrhosis, chronic kidney disease, or chronic lung disease).
        BMI ≥35 Kg/m2 Patients who refuse to participate in the study.

Study details
    Acute Pancreatitis

NCT05473260

Hospital Universitari de Bellvitge

20 August 2025

FAQs

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Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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