Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

Necrotizing Pancreatitis Clinical Trial

Official title:

Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815489
• Other study ID #: CHS-001
• Status: Completed
• Start date: July 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	California HealthCare Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cytokines	Blood samples will be taken from each patient to measure the level of different cytokines at the time of sample collection	June 2012
Secondary	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