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Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

This study is currently recruiting participants.
Verified March 2013 by Carolinas Healthcare System
Information provided by (Responsible Party):
David Sindram, Carolinas Healthcare System Identifier:
First received: August 1, 2012
Last updated: March 19, 2013
Last verified: March 2013

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.

Bacteria Infecting Necrotizing Pancreatitis
Systemic Inflammatory Response Syndrome
Comparison of Molecular Techniques for Bacterial Identification to Current Standard Culture Techniques

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

Resource links provided by NLM:

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Bacteria [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
    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:
  • Cytokines [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
    Blood samples will be taken from each patient to measure the level of different cytokines at the time of sample collection

  • Gastrointestinal Bacterial Flora [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT01815489

Contact: Erin M Hanna, MD 704-355-1162
Contact: Sherrie B Lee, RN, BSN 704-355-6220

United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Erin M Hanna, MD    704-355-1162   
Principal Investigator: David Sindram, MD, PhD         
Sponsors and Collaborators
Carolinas Healthcare System
Principal Investigator: David Sindram, MD Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: David Sindram, Attending Physician, Carolinas Healthcare System Identifier: NCT01815489     History of Changes
Other Study ID Numbers: CHS-001
Study First Received: August 1, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
Necrotizing Pancreatitis

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases
Pathologic Processes
Shock processed this record on April 14, 2014