Evidence map›Paper›PMID 21392395›Full record

Trial reportTrials2011

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

Olaf J Bakker, Hjalmar C van Santvoort, Sandra van Brunschot, Usama Ahmed Ali, Marc G Besselink, Marja A Boermeester, Thomas L Bollen, Koop Bosscha, Menno A Brink, Cornelis H Dejong and 19 more

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
5.3field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Nutrition support in hospitalised adults at nutritional risk.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Acute Pancreatitis Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2023
    Article
  8. Article
  9. Article
  10. [Nutritional therapy in acute pancreatitis].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2013
    Review
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 3 countries.

Olaf J BakkerDept, of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, PO 9101, 6500 HB Nijmegen; The Netherlands.
Hjalmar C van Santvoort
Sandra van Brunschot
Usama Ahmed Ali
Marc G Besselink
Marja A Boermeester
Thomas L Bollen
Koop Bosscha
Menno A Brink
Cornelis H Dejong
Erwin J van Geenen
Harry van Goor
Joos Heisterkamp
Alexander P Houdijk
Jeroen M Jansen
Thom M Karsten
Eric R Manusama
Vincent B Nieuwenhuijs
Bert van Ramshorst
Alexander F Schaapherder
George P van der Schelling
Marcel Bm Spanier
Adriaan Tan
Juda Vecht
Bas L Weusten
Ben J Witteman
Louis M Akkermans
Hein G Gooszen
Dutch Pancreatitis Study Group
University Medical Center Utrecht · NLSt. Antonius Ziekenhuis · NLRadboud University Medical Center · NLAcademic Medical Center · NLAmphia Ziekenhuis · NLAmsterdam UMC Location VUmc · NLCanisius-Wilhelmina Ziekenhuis · NLElisabeth-TweeSteden Ziekenhuis · NLIsala · NLLeiden University Medical Center · NLMeander Medisch Centrum · NLMedisch Centrum Alkmaar · NLMedisch Centrum Leeuwarden · NLOLVG · NLRadboud University Nijmegen · NLReinier de Graaf Hospital · NLRijnstate Hospital · NLRobert Bosch (Germany) · DEUniversity Medical Center · USUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission. METHODS/

designThe PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission.During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective. DISCUSSION: The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis.

trial registrationISRCTN: ISRCTN18170985.

Indexed as

Research DesignAcute DiseaseAPACHEBacterial InfectionsEnteral NutritionHumansNetherlandsPancreatitisSeverity of Illness IndexTime FactorsTreatment Outcome

Identifiers

PMID21392395
PMCPMC3068962
OpenAlexW2138898570

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.