Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

NCT01815489 | Completed

• 1 other identifier: CHS-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Pancreatitis

Keywords

Necrotizing Pancreatitis; Pancreatitis; Infection; Bacteria; Microbiology

Outcome Measures

Primary Outcomes (1)

• Bacteria

  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.

  June 2012

Secondary Outcomes (2)

• Cytokines

  June 2012

• Gastrointestinal Bacterial Flora

  June 2012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years old
• Participation in another device or drug study

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• California HealthCare Foundation: collaborator

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripancreatic fluid, pancreatic tissue, blood sample, stool sample

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Pancreatitis; Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• David Iannitti, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: March 21, 2013
• Study Start: July 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 26, 2022

Record last verified: 2014-05

Locations

US (1)