Early Oral Refeeding in Mild Acute Pancreatitis
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      Background The aim of the study is to compare the onset of oral feeding in the first 24 hours
      after hospital admission and determine if this influences the recurrence of pain or alters
      the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with
      mild acute pancreatitis Methods This Non-Inferiority Randomized controlled trial was carried
      out between September 2018 and June 2019, prior authorization from the ethics committee in
      health research. Patients with diagnosis of mild acute biliary pancreatitis, were divided
      into: Group A (early oral refeeding) and Group B (usual oral refeeding). Outcome measures
      were lipase pancreatic, systemic inflammatory response (concentrations of leukocytes) were
      used as marker for it, feasibility evaluated by abdominal pain recurrence, presence and
      recurrence of gastrointestinal symptoms and length of hospital stay. The aim of the present
      study is to compare the onset of oral feeding in the first 24 hours after hospital admission
      and determine if this influences the recurrence of pain or alters the blood levels of
      pancreatic enzymes, compared to usual oral refeeding in patients with mild acute
      pancreatitis.
    

Detailed description: 
      BACKGROUND Acute pancreatitis (AP) is an inflammatory pancreatic process, presents different
      severity degrees [1]. Over the last two decades, there has been a paradigm shift in the
      management, from surgical to "step up" approach using percutaneous or endoscopic catheter
      drainage followed by minimally invasive necrosectomy [2]. As no curative therapy is currently
      available for AP, early treatment consists of supportive care which includes adequate fluid
      resuscitation, pain management and enteral nutrition [3]. Pancreatic rest by Nil Per Oral
      (NPO) strategy was considered necessary in AP till abdominal pain get resolved and the levels
      of pancreatic and inflammatory markers decrease [4]. This trend has changed, now it is clear
      that the early oral refeeding for PA mild does not only provide adequate caloric intake, it
      may also improve clinical outcomes. It has been hypothesized that the combination of
      disturbed intestinal motility, microbial overgrowth and increased permeability of the gut can
      lead to bacterial translocation, thus causing infection of pancreatic necrosis [5,6].

      The oral refeeding (OR) may reduce translocation by stimulating intestinal motility, reducing
      bacterial overgrowth and thereby maintaining mucosal gut integrity [7,8]. Also decrease
      infection complications, organ failure and mortality as compared with routine total
      parenteral nutrition [9,10]. In patients with (predicted) mild pancreatitis, numerous studies
      concluded that a normal oral diet can be resumed once the pain is decreasing [11-13],
      However, it remains unclear what the optimal time to do it is. There is still no consensus
      about the definition of "early" refeeding.

      The aim of the present study is to compare the onset of oral feeding in the first 24 hours
      after hospital admission and determine if this influences the recurrence of pain or alters
      the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with
      mild acute pancreatitis.

      METHODS

      Patients This Randomized controlled trial was carried out between September 2018 and June
      2019, prior authorization from the ethics committee in health research.

      A total number of 124 patients were randomized in this study. The sample size was calculated
      according to the formula published by Bouemn et all 2015 [14], in which a percentage of
      success was estimated with the standard treatment of 90% compared to the experimental
      management of 85%, with a margin of no less than 10%, with an alpha for a tail of 0.05%, and
      a beta of 20 %, with a percentage of estimated losses of approximately 10%, a total of 62
      patients per group was obtained.

      Definitions The diagnosis of AP was established when the patient presents two or more of the
      following three findings: typical abdominal pain, elevation of serum pancreatic enzymes
      (amylase and/or lipase) at more than three times the upper limit of the normal value, and
      imaging study (ultrasonography or computed tomography) suggestive of AP [15].

      Severity Assessment Severity assessment of AP was done based on the revised Atlanta
      classification into mild, moderately severe and severe. Absence of organ failure or local or
      systemic complications was labelled as mild AP; of was defined using the modified Marshall
      scoring system [16]; and only the patients whose complete these severity criteria were
      randomized for the study.

      Protocol Once the diagnosis of acute biliary pancreatitis was confirmed and the course was
      mild, corresponding informed consent signed.

      Fluid therapy with crystalloid solution (Hartmann), initial bolus of 10 mL / kg and followed
      by infusion for 24 h of 1.5 mL / kg / h.

      Pain management with opioid weak tramadol 50mg every 6 hours and paracetamol 1 gram every 8
      hours with continuous evaluation of the analogue numerical scale to determine the need for
      extra doses

      Type of Diet:

      In both groups, their initial diet was the same so that this did not influence the results to
      be measured.

      The soft diet consisted of one of 900 Kcal per day, with 86.7% carbohydrates (190 g), 13.3%
      protein (30 g) and 0% lipids (0 g); during 24 h.

      When the diet was adequately tolerated and there was no evidence of clinical complications or
      deterioration, normal diet was indicated, and the follow-up continues.

      Data Collection:

      Laboratorial data, such as leukocytes, amylase and lipase were collected after inclusion in
      the study and after 24 and 48 h of oral refeeding. Clinical data records include age, gender,
      time from onset of pain baseline, Marshall score at admission and after start the oral
      feeding, gastrointestinal symptoms, abdominal pain, days until solid food intake, pain
      relapse, complications, length of hospital stay and readmissions.

      Statistical analysis Date are presented as frequency and percentage, comparisons between
      groups were using the χ2 test for binary data or Fisher´s exact test. Continuous variables
      are presented as median and range interquartile range and were compared using the
      Mann-Whitney U-test or t student test if they meet normal criteria. p-Values of less than
      0.05 were considered significant. Statistical analyses were performed with SPSS version
      25.0.0. Analysis by intention to treat was used.
    

Intervention name(s): early oral refeeding
Intervention type(s): Dietary Supplement
Intervention description(s): Once the patient had a score of 1-3 of the analogue numerical scale (ENA), he was interrogated about symptoms such as nausea or vomiting, receives diet indicated between 16 and 24 hours after admission.
Other intervention name(s): Early Vs Usual oral refeeding
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prior authorization from the ethics committee in health research. Patients with diagnosis of mild acute biliary pancreatitis, were divided into: Group A (early oral refeeding) and Group B (usual oral refeeding). Outcome measures were lipase pancreatic, systemic inflammatory response (concentrations of leukocytes) were used as marker for it, feasibility evaluated by abdominal pain recurrence, presence and recurrence of gastrointestinal symptoms and length of hospital stay.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild acute pancreatitis; Oral refeeding; Non inferiority clinical trial