Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis

Study Overview
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Brief Summary
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Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest. The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature. Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.

Detailed Description
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This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved. The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome: Length of hospital admission (the primary endpoint) Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests, C-reactive protein (biomarker of inflammation), nutritional parameters (albumin, prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests performed daily until normalization of serum lipase or until discharge. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up. 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.

Official Title
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Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis

Conditions
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Pancreatitis, Acute

Intervention / Treatment
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* Other: EARLY ORAL REFEEDING


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) 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) 2) age > 18 years, sign consent form. Exclusion Criteria: 1) pregnant o breastfeeding women; 2) abdominal pain lasting >96 horas before admission; 3) the possibility of poor oral intake for reasons other than AP; 4) Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology; 5) Chronic pancreatitis; 6) Randomization greater the 12 hours after admission

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early oral refeeding<br>The patients will be started the oral refeeding from the first day of admission in the hospital. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day | Other: EARLY ORAL REFEEDING<br>* the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day<br>|
| No Intervention: FASTING<br>The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | Days | measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 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 | measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge) | 
| Duration of fasting | Days | 2-3 days approximately since the first day of hospital admission | 
| Tolerance to food | The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals | 2-7 days approximately during hospital admission and during the follow up | 
| Elevation of serum amylase or lipase | Elevation amylase or lipase level after oral refeeding | 2-4 days approximately during hospital admission after oral refeeding, until hospital discharge | 
| Intra-abdominal infection | Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis | 1 month | 
| Death | Mortality | During hospital stay (up to 1 day) | 
| Operation rate | The rate of patients received operation for pancreatitis debridement | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pancreatitis, Oral refeeding, Nutrition, Length hospitalization