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TerminatedNCT00580749SNAPUpdated Jan 27, 2016

Study of Nutrition in Acute Pancreatitis

An interventional study of Naso jejunal feeding tube insertion and NG feeding tube insertion in Pancreatitis, sponsored by University of Pittsburgh. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-27.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Why this study was terminated
not meeting enrollment criteria
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

We will compare the two types of enteral (intestinal) nutrition in regard to patients with severe acute pancreatitis in our institution and also in 8 others in the United States.

02

Conditions studied

  • Pancreatitis

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Keywords

  • Pancreatitis
  • enteral feeding
  • distal jejunal feeding
  • naso gastric feeding
  • pancreatic rest
03

In context

Pancreatitis

759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 23 is below the median of 80 across 450 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients over the age of 18yr
  2. The typical history of abdominal pain for over 24h with raised (>3-fold) serum pancreatic enzymes on admission
  3. Severe pancreatitis, as defined by: the Atlanta classification of severe disease (60), but with important modifications to sharpen the definition of severity, to include one or more of the following:

    1. The presence of organ failure (MOF) resistant to early aggressive IV fluid resuscitation as defined by a Marshall score of ≥2 in any one organ (for calculation, see Appendix (61)), excluding the liver component as the abnormality may be due to gall stones rather than the systemic inflammatory response (17)
    2. Pancreatic necrosis >30% on CT scan or a modified CT severity index (CTSI: see Appendix (62)) of ≥8
    3. APACHE score ≥ 8 (for calculation, see Appendix (63))
    4. Ranson's criteria ≥3 (for calculation, see Appendix (64))

Exclusion criteria

Exclusion Criteria:

  1. Inability to absorb enteral nutrients resulting in chronic intestinal failure and need for IV feeding, such as short bowel, malabsorption disorders such as celiac or intestinal proliferative disorders, chronic obstruction and pseudo-obstruction.
  2. Time elapse since commencement of acute pancreatitis symptoms >10 days. In order to take advantage of the 'window of opportunity' to prevent the progression of 'transient' MOF to 'permanent' MOF, patients should be started on enteral feeding as soon as possible. However, in practice many patients present initially with mild disease which progresses to severe necrosis at the end of the first week, and these patients need nutritional support for long periods of time. Consequently, this is an important group to include in this investigation. Post hoc analysis will be performed to see whether they behave differently to patients fed earlier in their disease
  3. Any form of artificial feeding since commencement of acute pancreatitis symptoms
  4. Patients with chronic pancreatitis and pancreatic insufficiency requiring pancreatic enzyme supplements, based on clinical history and specific investigations such as by ERCP, MRP, or CT scanning.
  5. Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis, as this will make assessment of severity difficult
  6. Pre-existing end-stage liver disease with ascites, coagulopathy and encephalopathy, supported by biopsy, and/or radiological imaging and endoscopy (portal hypertension, varices and gastropathy), as this will make assessment of severity difficult
  7. Chronic immunodeficiency states such as AIDS defined by CD-4 count \< 50, and immunoglobulin deficiencies as it may independently affect feeding tolerance and infection risk
  8. Pancreatic cancer proven by biopsy, and any other form of cancer with life-expectancy \<6 months.
  9. Current somatostatin or corticosteroid therapy as these drugs will impair intestinal, metabolic, and immune function, and therefore affect absorption and infection risk.
  10. Contraindication to using the nose for enteral tube insertion
  11. Severe traumatic brain injury with ICP>20mmHg despite treatment
  12. Previous completion or withdrawal from this study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    DJ

    Naso disal jejunal(DJ) feedings randomized to 50% of subjects meeting criteria.

    Procedure: Naso jejunal feeding tube insertion

  • Active comparator
    NG

    Placement of naso gastric feeding tube through nare into stomach for enteral feeding.

    Procedure: NG feeding tube insertion

Interventions

  • ProcedureNaso jejunal feeding tube insertion

    Placement of feeding tube through nare and into jejunum for administration of enteral feeding.

  • ProcedureNG feeding tube insertion

    Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.

06

What researchers measure

Primary outcomes

  1. Feeding success as determined by the quantity of nutrition delivered and the number of interruptions due to intolerance and how the two forms of feeding influence disease outcome as measured by duration of ICU and hospital stay.

    Time frame: Approx. one week

Secondary outcomes

  1. Feeding tolerance (nitrogen balance, stool volume, incidence of nausea, incidence of nausea and vomiting) will demonstrate better tolerance for subjects undergoing DJ feeding than those undergoing NG feeding.

    Time frame: Approx. one week

07

Study locations

4 sites
  • University of Alabama
    Birmingham, Alabama 35294, United States
  • University of Florida College of Medicine
    Gainesville, Florida 32610, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15261, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00580749
Responsible party
David Whitcomb (MD, University of Pittsburgh) — Principal investigator
First posted
Dec 27, 2007
Start date
Jan 2010
Primary completion
May 2013
Completion
May 2013
Last update
Jan 27, 2016

Study contacts

David Whitcomb, MD
principal investigator · University of Pittsburgh

Oversight

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

Not currently enrolling

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

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