Acute PAncreatitis and Home Care vs. Hospital Admission Study

Study Overview
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Brief Summary
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Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction. With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology. Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.

Detailed Description
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This is prospective, randomized, controlled, multicentre trial. OBJECTIVES Primary objective Compare the results of 3 different strategies for the management of patients with mild acute pancreatitis (AP) and to analyze differences in satisfaction patients and economic costs. METHODS Patients with mild AP will be randomly in three groups: group A: outpatient treatment, group B: medical home care and group C: hospitalization. The primary and several secondary endpoints will be obtained: Treatment failure rate (the primary endpoint). Serum amylase, lipase, electrolytes, BUN (blood urea nitrogen), creatinine, liver function tests, and full blood count at hospital admission, 24 hours and 72 hours. Relapse pain. Diet intolerance. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures. Pain and Analgesic requirement. Local complications including pancreatic necrosis, abscess, pseudocyst. Health costs Patient satisfaction

Official Title
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Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis

Conditions
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Acute Pancreatitis, Home Care

Intervention / Treatment
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* Other: Outpatient
* Other: Medical home care
* Other: Hospitalization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI). age > 18 years, sign consent form. Exclusion Criteria: pregnant o breastfeeding women. abdominal pain lasting >96 horas before admission. the possibility of poor oral intake for reasons other than AP. Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction. Chronic pancreatitis. ASA ≥3. Randomization lesser the 24 hours after randomization.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Ramdomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient<br>The Mild AP patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center. | Other: Outpatient<br>* After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.<br>|
| Experimental: Medical home care<br>The mild AP patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center. | Other: Medical home care<br>* After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.<br>|
| Active Comparator: Hospitalization<br>The mild AP patient is hospitalized | Other: Hospitalization<br>* After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI_1) in each center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The treatment failure rate | Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of abdominal pain | Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain | 30 days | 
| Diet tolerance | Patient can eat at least 50% of the meals | 30 days | 
| Systemic Inflammatory Response Syndrome (SIRS) Score | SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation). | 4 days | 
| Number of Participants who Development of Organ Failure | Including respiratory, renal and cardiovascular failures defined as modified Marshal score of equal and greater than 2. The minimum and maximum values in the modified Marshal score for each organ failure range from 0 to 4 with a higher value representing worse outcomes. | 4 days | 
| Mortality | Enrolled subjects that died. A death indicates a worse outcome. | 30 days | 
| Hospital admission | The AP patient needs hospital admission due to treatment failure | 30 days | 
| Satisfaction medical / hospital care | patient satisfaction is asessed comparing management with and without admittance to the hospital. Will be assessed Patient satisfaction feedback (PSF). Scale: Strongly agree, Agree, Not sure, Disagree, Strongly disagree. | 30 days | 
| Health costs | The costs in euros caused by diagnosis, treatment, stay in the emergency room, complications and follow-up | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatitis