Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis. A Pilot Randomized Controlled Clinical Trial

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Other: Control
* Other: Experimental


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HOSPI Group<br>Patients with mild acute pancreatitis randomized to in-hospital care. | Other: Control<br>* In-patient care.<br>* Other names: HOSPIT;|
| Experimental: HOME Group<br>Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up. | Other: Experimental<br>* Early discharge and outpatient follow-up.<br>* Other names: HOME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day (after randomization) treatment failure rate | Treatment failure is defined as a VAS >3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis | Complications include, but are not limited to, abscess formation, pseudocysts, local necrosis, kidney failure, respiratory failure. | 30 days | 
| Hospital readmission during the first 30 days after diagnosis | Number of patients readmitted to the hospital during the first 30 days after diagnosis. | 30 days | 
| Cumulative incidence of mortality during the first 30 days after diagnosis | 30-day mortality | 30 days | 
| Estimated costs of each intervention |  | 7 days | 
| Median (95%CI) Charlson Comorbidity Score per group |  | 7 days | 
| Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pancreatitis, mild pancreatitis, outpatient protocol