Acute PancreatitisNCT02814071
Early Feeding in Acute Pancreatitis in Children
A study testing Early enteral feeding in people with Acute Pancreatitis, run by Shaare Zedek Medical Center at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Early enteral feeding
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2016to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Pediatric Gastroenterology, Sydney Children's Hospital
Sydney
About this study
Official title: Early Feeding in Acute Pancreatitis in Children - A Randomised Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Acute Pancreatitis
- Being tested
- Early enteral feeding
- Keywords
- Early Feeding, Acute Pancreatitis, Pediatric
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early enteral feedingOther
Early enteral feeding as per description
| Study group | Role | What they receive |
|---|---|---|
| Fasting with intravenous fluids | No intervention | 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 |
| Early enteral feeding | Experimental | 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. Receives: Other: Early enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ready for discharge
Measured: 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 outcomes (3)
Length of hospital stay
Measured: 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.
Time to clinical resolution of acute pancreatitis
Measured: 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.
Time to biochemical resolution of acute pancreatitis
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, oledder, Shaare Zedek Medical Center
- Investigators
- Oren Ledder, Dr., Principal investigator, Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814071
- Sponsor's protocol ID
- Early Feeding Pancreatitis
- Status last verified
- Mar 2020
- First submitted
- 23 May 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feeding in Acute Pancreatitis in Children - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02814071
- Acronym / sponsor ID
- Early Feeding Pancreatitis
- Conditions
- Acute Pancreatitis
- Keywords
- Early Feeding, Acute Pancreatitis, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting with intravenous fluids | No intervention | –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 |
| Early enteral feeding | Experimental | Other: Early enteral feedingPatients 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of acute pancreatitis according to international consensus criteria (Morinville et al. JPGN 2012), which requires at least 2 of the 3 following criteria:
- Age 3-18 years.
- Hemodynamically stable.
- Ability to consent and participate in the study and follow study procedures.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early enteral feedingEarly enteral feeding as per description | Other | Early enteral feeding |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oren Ledder, Dr. principal investigator
Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early enteral feeding in people with Acute Pancreatitis, run by Shaare Zedek Medical Center at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.