Trial record 6 of 244 for:    "Pancreatitis"

Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
California HealthCare Foundation
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01815489
First received: August 1, 2012
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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
Necrotizing Pancreatitis

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


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

  Eligibility

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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815489

Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
California HealthCare Foundation
Investigators
Principal Investigator: David Iannitti, MD Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: David Iannitti, Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01815489     History of Changes
Other Study ID Numbers: CHS-001
Study First Received: August 1, 2012
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
Necrotizing Pancreatitis
Pancreatitis
Infection
Bacteria
Microbiology

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014