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Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

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: NCT01815489
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : May 26, 2014
California HealthCare Foundation
Information provided by (Responsible Party):
David Iannitti, Atrium Health

Brief Summary:
Necrotizing pancreatitis is a severe form of inflammation of the pancreas with subsequent destruction of the pancreas (necrosis). Often, this condition manifests in patients as an overwhelming systemic inflammatory response and multisystem organ failure. Many times the pancreas can become superinfected with bacteria and other organisms as a result of this process. Clinicians may decide to sample fluid from the pancreas or pancreatic tissue to determine the presence of infection. This can be done through surgery with a concurrent debridement and drainage of the pancreas or by a radiologist using an ultrasound or CT guided method to sample the pancreatic fluid. These samples are then sent for culture in the microbiology laboratory. Culture results often reveal 1-2 types of infecting bacteria that originate from the gastrointestinal tract. The investigators hypothesize that in actuality, many different kinds of bacteria may infect the pancreas. This project uses molecular DNA techniques to help identify bacteria present in the pancreas of patients with severe necrotizing pancreatitis.

Condition or disease
Necrotizing Pancreatitis

Detailed Description:
In this study, patients with severe necrotizing pancreatitis will be followed prospectively throughout their hospital course (anticipated duration of hospitalization ranging between 4-8 weeks). If patients are suspected to have infection of pancreatic necrosis, they will be consented for enrollment. Patients will be determined by their attending physician to require either operative intervention or radiologic guided drainage of pancreatic necrosis and infected peripancreatic fluid. At the time of drainage procedure or intervention, one sample of peripancreatic fluid will be sent to the hospital's microbiology department for standard gram stain and bacterial culture identification and a second sample will be frozen for bacterial DNA analysis. Patients will be followed for the duration of their hospitalization for in hospital outcomes, mortality and final microbiology culture results. Samples will then be processed at six months and one year following sample collection for bacterial DNA deep sequencing analysis and will be compared to bacteria identified using standard culture technique.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis
Study Start Date : July 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Primary Outcome Measures :
  1. Bacteria [ Time Frame: June 2012 ]
    Bacteria present in peri-pancreatic fluid and pancreatic tissue will be analyzed and identified suing molecular based methods. Comparisons will be made to bacteria identified using standard culture techniques.

Secondary Outcome Measures :
  1. Cytokines [ Time Frame: June 2012 ]
    Blood samples will be taken from each patient to measure the level of different cytokines at the time of sample collection

  2. Gastrointestinal Bacterial Flora [ Time Frame: June 2012 ]
    A small stool sample will be taken from each patient to determine normal GI flora that may be translocating to the pancreas in patients with severe pancreatitis.

Biospecimen Retention:   Samples With DNA
Peripancreatic fluid, pancreatic tissue, blood sample, stool sample

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults over 18 years of age with a diagnosis of necrotizing pancreatitis and concern for superinfection of the pancreas related to their condition.

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Severe necrotizing pancreatitis as evidenced by clinical examination, biochemical analysis, and/or imaging studies demonstrating pancreatitis and pancreatic necrosis

Exclusion Criteria:

  • Age less than 18 years old
  • Participation in another device or drug 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): NCT01815489

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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
California HealthCare Foundation
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Principal Investigator: David Iannitti, MD Atrium Health
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Responsible Party: David Iannitti, Investigator, Atrium Health Identifier: NCT01815489    
Other Study ID Numbers: CHS-001
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014
Keywords provided by David Iannitti, Atrium Health:
Necrotizing Pancreatitis
Additional relevant MeSH terms:
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Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases