Study of Nutrition in Acute Pancreatitis (SNAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00580749
Recruitment Status : Terminated (not meeting enrollment criteria)
First Posted : December 27, 2007
Last Update Posted : January 27, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Whitcomb, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatitis Procedure: Naso jejunal feeding tube insertion Procedure: NG feeding tube insertion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feeding and Pancreatic Rest in Acute Pancreatitis
Study Start Date : January 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: DJ
Naso disal jejunal(DJ) feedings randomized to 50% of subjects meeting criteria.
Procedure: Naso jejunal feeding tube insertion
Placement of feeding tube through nare and into jejunum for administration of enteral feeding.

Active Comparator: NG
Placement of naso gastric feeding tube through nare into stomach for enteral feeding.
Procedure: NG feeding tube insertion
Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00580749

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: David Whitcomb, MD University of Pittsburgh

Responsible Party: David Whitcomb, MD, University of Pittsburgh Identifier: NCT00580749     History of Changes
Other Study ID Numbers: PRO 07080011, PRO 07080044
1 R01 DK 075803-01A1 NIH#
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: June 2013

Keywords provided by David Whitcomb, University of Pittsburgh:
enteral feeding
distal jejunal feeding
naso gastric feeding
pancreatic rest

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases