Clinical trial NCT01815489: Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis
Official title: Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Pancreatitis
Keywords: Necrotizing Pancreatitis
Pancreatitis
Infection
Bacteria
Microbiology
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: California HealthCare Foundation
First posted: 2013-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Bacteria
timeFrame: June 2012
Secondary outcomes:
measure: Cytokines
timeFrame: June 2012
measure: Gastrointestinal Bacterial Flora
timeFrame: June 2012
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David Iannitti, MD
role: PRINCIPAL_INVESTIGATOR
References: