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

Conditions

Acute pancreatitis Digestive System Acute pancreatitis

Olaf J. Bakker, Sandra van Brunschot, Hjalmar C. van Santvoort, Marc G. Besselink, Thomas L. Bollen et al. (31 authors)

New England Journal of Medicine2014-11-20326 citations

Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial.

Bakker OJ, van Santvoort HC, van Brunschot S, Ahmed Ali U, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Brink MA, Dejong CH, van Geenen EJ, van Goor H, Heisterkamp J, Houdijk AP, Jansen JM, Karsten TM, Manusama ER, Nieuwenhuijs VB, van Ramshorst B, Schaapherder AF, van der Schelling GP, Spanier MB, Tan A, Vecht J, Weusten BL, Witteman BJ, Akkermans LM, Gooszen HG, Dutch Pancreatitis Study Group.

2011-03-1026 citations

10.1186/1745-6215-12-73

Interventions

A total of 208 patients will be randomised in 20 participating centres of the Dutch Pancreatitis Study Group (approximately 10 patients per centre). Patients are randomised to Group A

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Fraction of patients with an infectious complication or mortality during hospital admission and until 90 days postdischarge (composite endpoint). Re-admission within 10 days after discharge is considered as a continued hospital admission. Definition of infections: a. Infected pancreatic necrosis = positive culture after first percutaneous drainage procedure of collection with (peri-) pancreatic necrosis or after first surgical necrosectomy b. Positive blood culture = positive culture in 1 blood culture. In case of coagulase negative staphylococci or other non-virulent micro-organisms at least 2 blood culture bottles are mandatory c. Pneumonia = coughing, dyspnoea, radiography with infiltrative abnormalities and positive culture in sputum. On the intensive care unit a positive endotracheal culture is mandatory.	—

Measure

Time frame

Fraction of patients with an infectious complication or mortality during hospital admission and until 90 days postdischarge (composite endpoint). Re-admission within 10 days after discharge is considered as a continued hospital admission. Definition of infections: a. Infected pancreatic necrosis = positive culture after first percutaneous drainage procedure of collection with (peri-) pancreatic necrosis or after first surgical necrosectomy b. Positive blood culture = positive culture in 1 blood culture. In case of coagulase negative staphylococci or other non-virulent micro-organisms at least 2 blood culture bottles are mandatory c. Pneumonia = coughing, dyspnoea, radiography with infiltrative abnormalities and positive culture in sputum. On the intensive care unit a positive endotracheal culture is mandatory.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 14/07/2008: The following will be assessed during hospital admission and until 90 days postdischarge: 1. Individual components of the primary endpoint 2. Urinary tract infection (dysuria with bacteruria >10.000 Colony Forming Units [CFU]/mL) 3. Nutrition related complications: diarrhea, aspiration pneumonia, pneumothorax due to central TPN catheter placement 4. Need for conversion from EN to TPN 5. Days until intake of solid food 6. Use of antibiotics 7. Pain relapse, measured once daily during start of oral refeeding with the Visual Analogue Scale (VAS; 0 to 10, 0 = no pain, 10 = unbearable pain) 8. CRP and leukocytes as measures of systemic inflammation 9. Length of hospital stay 10. Need for ICU admission 11. New onset organ failure (onset, extent and duration, see definitions section) 12. Length of ICU stay 13. Need for percutaneous drainage 14. Need for surgical or endoscopical necrosectomy 15. Gastrointestinal permeability measured with the PolyEthylene Glycol (PEG) test 16. Hand grip muscular strength measured by the Jamar dynamometer 17. Quality of life will be measured using EQ-5D questionnaire 18. Total direct and indirect costs Previous secondary outcome measures: The following will be assessed during hospital admission and until 90 days postdischarge: 1. Individual components of the primary endpoint 2. Urinary tract infection (dysuria with bacteruria >10.000 Colony Forming Units [CFU]/mL) 3. Nutrition related complications: diarrhea, aspiration pneumonia, pneumothorax due to central TPN catheter placement 4. Need for con	—

Measure

Time frame

Current secondary outcome measures as of 14/07/2008: The following will be assessed during hospital admission and until 90 days postdischarge: 1. Individual components of the primary endpoint 2. Urinary tract infection (dysuria with bacteruria >10.000 Colony Forming Units [CFU]/mL) 3. Nutrition related complications: diarrhea, aspiration pneumonia, pneumothorax due to central TPN catheter placement 4. Need for conversion from EN to TPN 5. Days until intake of solid food 6. Use of antibiotics 7. Pain relapse, measured once daily during start of oral refeeding with the Visual Analogue Scale (VAS; 0 to 10, 0 = no pain, 10 = unbearable pain) 8. CRP and leukocytes as measures of systemic inflammation 9. Length of hospital stay 10. Need for ICU admission 11. New onset organ failure (onset, extent and duration, see definitions section) 12. Length of ICU stay 13. Need for percutaneous drainage 14. Need for surgical or endoscopical necrosectomy 15. Gastrointestinal permeability measured with the PolyEthylene Glycol (PEG) test 16. Hand grip muscular strength measured by the Jamar dynamometer 17. Quality of life will be measured using EQ-5D questionnaire 18. Total direct and indirect costs Previous secondary outcome measures: The following will be assessed during hospital admission and until 90 days postdischarge: 1. Individual components of the primary endpoint 2. Urinary tract infection (dysuria with bacteruria >10.000 Colony Forming Units [CFU]/mL) 3. Nutrition related complications: diarrhea, aspiration pneumonia, pneumothorax due to central TPN catheter placement 4. Need for con

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Countries

Netherlands

Outcome results

None listed