Acute Pancreatitis Clinical Trial in Sydney
NCT02814071
| Interventional
This study has recruited 33 Participants
Acute pancreatitis (AP) in children has an increasing incidence and is at times associated
with significant morbidity and mortality. Despite this, there is no high-quality
evidence-based treatment for childhood AP and current practice is based entirely on
historical approach and extrapolation from adult studies.
In this study, we evaluate the use of early enteral feeding in children with AP. The
traditional approach to treating AP relies on fasting and intravenous fluids (or occasionally
parenteral nutrition) assuming that this minimizes stimulation of an already inflamed
pancreas. Contrary to this, evidence exists that early feeding of patients with AP may be
beneficial. Randomized controlled trials of fasting vs. early oral diet in adult patients
with mild AP, showed no differences in pain, serum amylase and CRP levels, but also shorter
hospital stay in those fed earlier. Further data in adults with severe AP demonstrated that
early enteral nutrition was associated with decreased mortality, infections and multiorgan
failure. These benefits were lost if enteral nutrition was commenced 48 hour after admission.
Suggested explanations for these findings include the possibility that enteral nutrition may
maintain integrity and function of intestinal mucosa and reduce gut-origin sepsis.
Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in
the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require
moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data
suggest that oral feeding with a low fat diet was as safe as NJ feeding.
Several animal models of AP demonstrate that the exocrine pancreas is resistant to
cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack
of concern of exacerbating pancreatitis with enteral feeds.
Considering this data it is less certain that diet and fat restriction contribute to
treatment of AP. To further challenge the prior conceptions of AP management it is necessary
to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a
population with recognized low complication risk.
Despite the mounting evidence to the contrary, it is still standard clinical practice to fast
children with AP, and only slowly reintroduce feeds depending on the clinical improvement.
This is largely due to the lack of clinical interventional studies in children with AP.
Details for the study
Brief Title
Early Feeding in Acute Pancreatitis in Children
Official Title
Early Feeding in Acute Pancreatitis in Children - A Randomised Controlled Trial
Brief Summary
Acute pancreatitis (AP) in children has an increasing incidence and is at times associated<br /> with significant morbidity and mortality. Despite this, there is no high-quality<br /> evidence-based treatment for childhood AP and current practice is based entirely on<br /> historical approach and extrapolation from adult studies.<br /><br /> In this study, we evaluate the use of early enteral feeding in children with AP. The<br /> traditional approach to treating AP relies on fasting and intravenous fluids (or occasionally<br /> parenteral nutrition) assuming that this minimizes stimulation of an already inflamed<br /> pancreas. Contrary to this, evidence exists that early feeding of patients with AP may be<br /> beneficial. Randomized controlled trials of fasting vs. early oral diet in adult patients<br /> with mild AP, showed no differences in pain, serum amylase and CRP levels, but also shorter<br /> hospital stay in those fed earlier. Further data in adults with severe AP demonstrated that<br /> early enteral nutrition was associated with decreased mortality, infections and multiorgan<br /> failure. These benefits were lost if enteral nutrition was commenced 48 hour after admission.<br /> Suggested explanations for these findings include the possibility that enteral nutrition may<br /> maintain integrity and function of intestinal mucosa and reduce gut-origin sepsis.<br /><br /> Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in<br /> the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require<br /> moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data<br /> suggest that oral feeding with a low fat diet was as safe as NJ feeding.<br /><br /> Several animal models of AP demonstrate that the exocrine pancreas is resistant to<br /> cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack<br /> of concern of exacerbating pancreatitis with enteral feeds.<br /><br /> Considering this data it is less certain that diet and fat restriction contribute to<br /> treatment of AP. To further challenge the prior conceptions of AP management it is necessary<br /> to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a<br /> population with recognized low complication risk.<br /><br /> Despite the mounting evidence to the contrary, it is still standard clinical practice to fast<br /> children with AP, and only slowly reintroduce feeds depending on the clinical improvement.<br /> This is largely due to the lack of clinical interventional studies in children with AP.
Detailed Description
This is a prospective, randomized controlled trial in children with acute pancreatitis, which
aims to demonstrate that, compared with the current standard approach of fasting with
intravenous fluids, early enteral (oral or nasogastric) feeding with standard diet or formula
will improve the following measures of outcome:
1. Length of hospital admission.
2. Serum amylase, lipase, electrolytes, calcium, magnesium, phosphate, urea, creatinine,
liver function tests, C-reactive protein (biomarker of inflammation), and full blood
count - routine blood tests performed daily until normalisation of serum lipase or until
discharge and as directed by treating clinician thereafter.
3. Weight at presentation and "ready for discharge", and at day 30 post-discharge clinic
review.
4. Systemic complications including hemodynamic instability, renal failure, intensive care
admission.
5. Analgesic requirement.
6. Local complications including pancreatic necrosis, abscess, pseudocyst.
7. Abdominal ultrasound findings during hospital admission (or other abdominal imaging as
directed by treating clinicians).
At day 30-60 post-discharge, a routine ultrasound (to assess for localized complication(s)
e.g. pseudocyst) and clinical follow-up will be undertaken.
Treatments and/or Procedures
Early enteral feeding
Early enteral feeding as per description
Study Criteria
Inclusion Criteria:
1. Diagnosis of acute pancreatitis according to international consensus criteria
(Morinville et al. JPGN 2012), which requires at least 2 of the 3 following criteria:
- Abdominal pain compatible with acute pancreatitis
- Serum amylase and/or lipase ≥ 3 times upper limits of normal
- Imaging findings consistent with acute pancreatitis Each episode of acute
recurrent pancreatitis will be accepted if each episode is distinct, at least 4
weeks apart from previous episode with intervening normalisation of serum amylase
and lipase.
2. Age 3-18 years.
3. Hemodynamically stable.
4. Ability to consent and participate in the study and follow study procedures.
Exclusion Criteria:
1. Severe pancreatitis associated with organ dysfunction and requiring intensive care
admission at presentation.
2. Biliary cause of pancreatitis including gallstone pancreatitis and choledochal cyst
3. Autoimmune pancreatitis.
4. High grade traumatic pancreatitis including partial or complete disruption of the
pancreatic duct.
5. Presence of other conditions restricting enteral nutrition.
6. Different treatment approach taken by treating clinician due to medical reasons.