Study of Nutrition in Acute Pancreatitis (SNAP)

January 26, 2016 updated by: David Whitcomb, University of Pittsburgh

Feeding and Pancreatic Rest in Acute Pancreatitis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Approx. one week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Approx. one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: David Whitcomb, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO 07080011, PRO 07080044
  • 1 R01 DK 075803-01A1 NIH#

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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