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Status unknownNCT02000323Updated Dec 4, 2013

Early Enteral Nutrition in Severe Acute Pancreatitis

An interventional study of early enteral nutrition and modified early enteral nutrition in Pancreatitis, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-12-04.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

to compare different time points for enteral nutrition in SAP patients

Read the detailed description

There is increasing evidence that indicates Early Enteral Nutrition(EEN) may be associated with improved outcome in acute pancreatitis patients. However, some SAP patients failed to EEN. The researchers of this study aim to investigate the opportunity of EEN on the clinical outcomes of SAP patients.

02

Conditions studied

  • Pancreatitis

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Keywords

  • pancreatitis
  • enteral nutrition
03

In context

Pancreatitis

751 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
  2. Onset of abdominal pain within \<=72h before admission
  3. moderate severe or severe Acute Pancreatitis according to Atlanta criteria revisited in 2012 ffff

Exclusion criteria

Exclusion Criteria:

    1. Pregnancy 2.tumor 3. acute onset of chronic pancreatitis
  1. chronic disease of any organ (heart lung gastrointestinal renal etc.) 5. Pre-existing disease with life expectancy \< 3 months 7.receive parenteral nutrition or enteral nutrition before admitting
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    early enteral nutrition

    Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Standard enteral nutrition liquid regimen (Peptisorb Liquid)will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.

    Other: early enteral nutrition

  • Active comparator
    modified early enteral nutrition

    Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Only Normal Saline were given through Naso-gastro-Jejunal tube until 2 or more followed requirements were met mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure \<20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.

    Other: modified early enteral nutrition

Interventions

  • Otherearly enteral nutrition

    Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. • After catharsis, Standard enteral nutrition liquid regimen will be used step by step. Patients are targeted to receive calories for 25 kcal/kg/day. nutrition form: short peptide ,1 kcal/ml,target 200k kcal/day

  • Othermodified early enteral nutrition

    Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Only Normal Saline were given through nasojejunal tube until 2 or more followed requirements were meted (mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure \<20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.

06

What researchers measure

Primary outcomes

  1. mortality

    the rate of patients died

    Time frame: 28days

Secondary outcomes

  1. operation rate

    The rate of patients received operation for pancreatitis debridement

    Time frame: 2 months

  2. fulfilling enteral nutrition target(≥25Kcal/kg/day)

    enteral nutrition target set as ≥25Kcal/kg/day

    Time frame: 7 days

Other outcomes

  1. inta-abdominal infection

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Ruijin
    Shanghai, Shanghai, China
    • Zhen Er Chen, PHD · Contact · elmaxuwen@gmail.com · 64370045
    • xu Wen · Principal investigator
    Recruiting
08

References and documents

Publications

  • Ong JP, Fock KM. Nutritional support in acute pancreatitis. J Dig Dis. 2012 Sep;13(9):445-52. doi: 10.1111/j.1751-2980.2012.00611.x. PubMed 22908969 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02000323
Lead sponsor
Ruijin Hospital
Collaborators
RenJi Hospital
Responsible party
Erzhen Chen (Prefessor, Ruijin Hospital) — Principal investigator
First posted
Dec 4, 2013
Start date
Aug 2012
Primary completion
Sep 2016 (estimated)
Completion
Aug 2017 (estimated)
Last update
Dec 4, 2013

Study contacts

Zhen Er chen, PHD
Contact
chenerzhen@hotmail.com
64370045 ext. 665520
qiang En mao
Contact
Qiang en Mao, phd
study director · Emergency intensive care unit of Ruijin Hospital
Wen xu, Master
principal investigator · doctor

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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