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Study of Nutrition in Acute Pancreatitis (SNAP)

Primary Purpose

Pancreatitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naso jejunal feeding tube insertion
NG feeding tube insertion
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Pancreatitis, enteral feeding, distal jejunal feeding, naso gastric feeding, pancreatic rest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • University of Florida College of Medicine
  • Indiana University
  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DJ

NG

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 21, 2007
Last Updated
January 26, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00580749
Brief Title
Study of Nutrition in Acute Pancreatitis
Acronym
SNAP
Official Title
Feeding and Pancreatic Rest in Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
not meeting enrollment criteria
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Pancreatitis, enteral feeding, distal jejunal feeding, naso gastric feeding, pancreatic rest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DJ
Arm Type
Active Comparator
Arm Description
Naso disal jejunal(DJ) feedings randomized to 50% of subjects meeting criteria.
Arm Title
NG
Arm Type
Active Comparator
Arm Description
Placement of naso gastric feeding tube through nare into stomach for enteral feeding.
Intervention Type
Procedure
Intervention Name(s)
Naso jejunal feeding tube insertion
Intervention Description
Placement of feeding tube through nare and into jejunum for administration of enteral feeding.
Intervention Type
Procedure
Intervention Name(s)
NG feeding tube insertion
Intervention Description
Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18yr The typical history of abdominal pain for over 24h with raised (>3-fold) serum pancreatic enzymes on admission 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: 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) Pancreatic necrosis >30% on CT scan or a modified CT severity index (CTSI: see Appendix (62)) of ≥8 APACHE score ≥ 8 (for calculation, see Appendix (63)) Ranson's criteria ≥3 (for calculation, see Appendix (64)) Exclusion Criteria: 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. 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 Any form of artificial feeding since commencement of acute pancreatitis symptoms 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. Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis, as this will make assessment of severity difficult 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 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 Pancreatic cancer proven by biopsy, and any other form of cancer with life-expectancy <6 months. Current somatostatin or corticosteroid therapy as these drugs will impair intestinal, metabolic, and immune function, and therefore affect absorption and infection risk. Contraindication to using the nose for enteral tube insertion Severe traumatic brain injury with ICP>20mmHg despite treatment Previous completion or withdrawal from this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Whitcomb, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

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Study of Nutrition in Acute Pancreatitis

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