Inmediate Feeding Tolerance in Acute Pancreatitis

Study Overview
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Brief Summary
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Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning of treatment) against traditional management (early feeding at 48hr) in patients with mild acute pancreatitis of biliary origin. Double blind, randomized clinical trial

Detailed Description
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The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute pancreatitis according to the Ranson, APACHE II and BISAP. Signed infromed consent to participate in the study. All participants had a hepatic and biliary ultrasound to determine the biliary etiology. The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant, severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay or with other comorbidities.

Official Title
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Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding

Conditions
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Acute Pancreatitis Due to Gallstones

Intervention / Treatment
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* Dietary Supplement: TIME OF FEEDING


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 15 years. Patients with a diagnosis of mild acute pancreatitis biliary. Patients who agree to enter the protocol. Exclusion Criteria: Patients managed at another institution. Patients with a diagnosis of pancreatitis of non-biliary etiology. Patients with heart disease or lung disease. Patients with organic failure. Patients with pregnancy. Patients with cholangitis.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early oral feeding<br>TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet) | Dietary Supplement: TIME OF FEEDING<br>* Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)<br>|
| Experimental: Immediate oral feeding<br>TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula) | Dietary Supplement: TIME OF FEEDING<br>* Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatitis reactivation after oral Feeding | Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation | Measures at 24hours after the begining of the oral intake | 
| Pancreatitis reactivation after oral Feeding | Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation | Measures at 48hours after the begining of the oral intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatitis, mild, biliary, referring