Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis
Condition: Pancreatitis, Acute
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      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: 
      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:

        1. Length of hospital admission (the primary endpoint)

        2. 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.

        3. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic
           follow-up.

        4. Systemic complications including hemodynamic instability, renal failure, intensive care
           admission, surgery, radiological and endoscopic procedures.

        5. Pain and Analgesic requirement.

        6. Local complications including pancreatic necrosis, abscess, pseudocyst.
    

Intervention name(s): EARLY ORAL REFEEDING
Intervention type(s): Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Pancreatitis; Oral refeeding; Nutrition; Length hospitalization