search
Back to results

Early Feeding in Acute Pancreatitis in Children

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Early enteral feeding
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring Early Feeding, Acute Pancreatitis, Pediatric

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Pediatric Gastroenterology, Sydney Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Fasting with intravenous fluids

Early enteral feeding

Arm Description

The child will be kept fasted. Intravenous fluids will be at a rate and type as directed by the treating clinician. A low fat oral diet will be commenced once abdominal pain resolves and serum amylase/lipase levels decrease from the peak levels as per treating clinician. In the event that the patient is unable to tolerate oral feeding, tube feeding or parenteral nutrition may be commenced based on the clinical decision of the treating clinician(s). This will be recorded as an adverse event. Patients will be re-trialed on oral feeds once initial limiting symptoms or factors have improved or settled as per treating clinician's discretion

Patients will commence on an unrestricted oral diet within 24 hours of presentation, meeting 50% of EER with a regular diet and no fat restriction for the first 24 hours of enteral feeding. A 75-100% EER is targeted ≥ 24 hours of enteral feeding.If the targeted EER is not met orally, a nasogastric tube will be inserted to provide bolus feeds of a standard formula with standard fat content. If the patient fails to tolerate both oral and bolus nasogastric tube feeding, continuous nasogastric tube feeding will be provided. If all fails, enteral nutrition by nasojejunal tube feeding or parenteral nutrition may be commenced based on the clinical decision. Patients will be re-trialed on oral feeds once initial limiting symptoms or factors have improved or settled.

Outcomes

Primary Outcome Measures

Time to ready for discharge

Secondary Outcome Measures

Length of hospital stay
Time to clinical resolution of acute pancreatitis
Time to biochemical resolution of acute pancreatitis

Full Information

First Posted
May 23, 2016
Last Updated
March 17, 2020
Sponsor
Shaare Zedek Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02814071
Brief Title
Early Feeding in Acute Pancreatitis in Children
Official Title
Early Feeding in Acute Pancreatitis in Children - A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Length of hospital admission. 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. Weight at presentation and "ready for discharge", and at day 30 post-discharge clinic review. Systemic complications including hemodynamic instability, renal failure, intensive care admission. Analgesic requirement. Local complications including pancreatic necrosis, abscess, pseudocyst. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
Early Feeding, Acute Pancreatitis, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasting with intravenous fluids
Arm Type
No Intervention
Arm Description
The child will be kept fasted. Intravenous fluids will be at a rate and type as directed by the treating clinician. A low fat oral diet will be commenced once abdominal pain resolves and serum amylase/lipase levels decrease from the peak levels as per treating clinician. In the event that the patient is unable to tolerate oral feeding, tube feeding or parenteral nutrition may be commenced based on the clinical decision of the treating clinician(s). This will be recorded as an adverse event. Patients will be re-trialed on oral feeds once initial limiting symptoms or factors have improved or settled as per treating clinician's discretion
Arm Title
Early enteral feeding
Arm Type
Experimental
Arm Description
Patients will commence on an unrestricted oral diet within 24 hours of presentation, meeting 50% of EER with a regular diet and no fat restriction for the first 24 hours of enteral feeding. A 75-100% EER is targeted ≥ 24 hours of enteral feeding.If the targeted EER is not met orally, a nasogastric tube will be inserted to provide bolus feeds of a standard formula with standard fat content. If the patient fails to tolerate both oral and bolus nasogastric tube feeding, continuous nasogastric tube feeding will be provided. If all fails, enteral nutrition by nasojejunal tube feeding or parenteral nutrition may be commenced based on the clinical decision. Patients will be re-trialed on oral feeds once initial limiting symptoms or factors have improved or settled.
Intervention Type
Other
Intervention Name(s)
Early enteral feeding
Intervention Description
Early enteral feeding as per description
Primary Outcome Measure Information:
Title
Time to ready for discharge
Time Frame
Time to ready for discharge- measured from onset of admission to time when medically assessed ready for discharge. Assessed between 5-10 days up to 14 days.
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Length of hospital stay- measured from onset of admission until time of actual discharge from hospital. Assessed between 5-10 days up to 14 days.
Title
Time to clinical resolution of acute pancreatitis
Time Frame
Time to clinical resolution of acute pancreatitis- time from onset of hospital admission until painfree and absence of nausea with no need for analgesia or other symptomatic therapy. Assessed between 5-10 days up to 14 days.
Title
Time to biochemical resolution of acute pancreatitis
Time Frame
Time to biochemical resolution of acute pancreatitis- time from onset of hospital admission to resolution of lipase and/or amylase below upper limit of normal. Assessed between 5-10 days up to 14 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Age 3-18 years. Hemodynamically stable. Ability to consent and participate in the study and follow study procedures. Exclusion Criteria: Severe pancreatitis associated with organ dysfunction and requiring intensive care admission at presentation. Biliary cause of pancreatitis including gallstone pancreatitis and choledochal cyst Autoimmune pancreatitis. High grade traumatic pancreatitis including partial or complete disruption of the pancreatic duct. Presence of other conditions restricting enteral nutrition. Different treatment approach taken by treating clinician due to medical reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oren Ledder, Dr.
Organizational Affiliation
Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Gastroenterology, Sydney Children's Hospital
City
Sydney
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Feeding in Acute Pancreatitis in Children

We'll reach out to this number within 24 hrs