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Pancreatitis, very early compared with selective delayed start of enteral feeding (PYTHON) trial

Not Applicable
Completed
Conditions
Acute pancreatitis
Digestive System
Registration Number
ISRCTN18170985
Lead Sponsor
niversity Medical Centre Utrecht (Netherlands)
Brief Summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21392395 2014 results in https://pubmed.ncbi.nlm.nih.gov/25409371/ (added 30/12/2020)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
208
Inclusion Criteria

1. Diagnosis of acute pancreatitis, requiring 2 of the 3 following features:
1.1. Upper abdominal pain
1.2. Serum lipase and/or amylase levels 3 times the upper level of normal
1.3. Characteristic findings of acute pancreatitis on Computerised Tomography (CT) scan
2. Age 18 years or older
3. Written informed consent
4. Patients with predicted severe acute pancreatitis defined as Imrie score >2 or Acute Physiology And Chronic Health Evaluation II (APACHE-II) score >7 or C-Reactive Protein (CRP) level >150 mg/L (within 24 hours of admission to the hospital)

Exclusion Criteria

1. History of acute or chronic pancreatitis
2. Admitted to hospital >24 hours (either for AP or for other conditions)
3. Symptoms >96 hours (4 days)
4. AP due to malignancy
5. Diagnosis of AP during operation for acute abdomen
6. Post Endoscopic Retrograde CholangioPancreatography (ERCP) pancreatitis
7. Already on artificial nutrition (EN or PN)
8. Pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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