Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokines	Blood samples will be taken from each patient to measure the level of different cytokines at the time of sample collection	June 2012
Gastrointestinal Bacterial Flora	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.	June 2012

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: California HealthCare Foundation

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimate): March 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Infection; Bacteria; Microbiology; Pancreatitis; Necrotizing Pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: CHS-001