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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOSPI Group | Active Comparator | Patients with mild acute pancreatitis randomized to in-hospital care. |
|
| HOME Group | Experimental | Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | In-patient care. |
|
|
| 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 |
| 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 |
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INCLUSION CRITERIA
Patients diagnosed with mild acute pancreatitis based on at least two of the three following criteria:
Age ≥18 years and <80 years
Absence of potential pancreatitis-related severity criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juli Busquets, PhD | Contact | 93 260 75 00 | jbusquets@bellvitgehospital.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Experimental |
| Other |
Early discharge and outpatient follow-up. |
|
|
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 |