Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis

Pancreatitis Clinical Trial

— STREM-1  

Official title:

Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis: a Marker of Infected Necrosis and Indicator of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193413
• Other study ID #: Changhai-100829
• Secondary ID: 30772138
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: September 1, 2010
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: September 2009
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Early diagnosis of secondary infection of necrotic tissue in severe acute pancreatitis is extremely important. The investigators evaluated whether the level of soluble TREM-1 (sTREM-1) in fine needle aspiration (FNA) fluid from patients who suspected infection is a good marker of secondary infection of necrotic tissue and an indicator of the proper treatment between drainage and necrosectomy.

Description:

The major cause of death, next to early organ failure, is secondary infection of pancreatic or peripancreatic necrotic tissue, leading to sepsis and multiple organ failure. The diagnosis and treatment of infected necrosis in SAP remain a major challenge for clinicians. The necrotic infection is defined when microorganisms are isolated from the samples of ultrasound or computed tomography (CT) guided fine needle aspiration (FNA). Unfortunately, a negative biopsy result can not completely rule out infection and the repeated aspirations may lead to bleeding or iatrogenic infection. Moreover, whatever the microbiologic diagnostic procedure chosen, further laboratory processing and delays of 24 to 48 hours are required for definitive quantitative microbial culture results. Meanwhile, clinicians often feel uncomfortable about the diagnosis and may administer unneeded antibiotics while awaiting laboratory results.

Secondary infection of necrotic tissue in SAP patients is virtually always an indication for intervention. The traditional approach is open necrosectomy to completely remove the infected necrotic tissue. This invasive approach is associated with high rates of complications (34 to 95%) and death (11 to 39%).As an alternative to open necrosectomy, less invasive techniques, including percutaneous drainage and endoscopic (transgastric) drainage, are increasingly being used.These steps may postpone or even obviate surgical necrosectomy with reducing complications and death.It remains uncertain which intervention is optimal in terms of clinical conditions of these patients and the severity of local infection.

Therefore, many biologic markers have been studied in an effort to improve the diagnostic rate and determine the the severity of necrosis infection but with disappointing results. The triggering receptor expressed on myeloid cells (TREM-1) is a member of the immunoglobulin superfamily whose expression on phagocytes is up-regulated by exposure to bacteria and fungi. TREM-1 mediates the acute inflammatory response to microbial products.[27] TREM-1 is also shed by the membrane of activated phagocytes and can be found in a soluble form in body fluids. We evaluated whether the lever of soluble TREM-1 (sTREM-1) in FNA fluid from patients who suspected infection is a good marker of secondary infection of necrotic tissue and an indicator of the proper treatment between drainage and necrosectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Diagnosis of severe pancreatitis

• Pancreatic or peripancreatic necrosis

• Body temperature at least 38.3°C

• Leukocytosis (more than 10,000 leukocytes per cubic millimeter) or leukopenia (fewer than 4000 leukocytes per cubic millimeter)

Exclusion Criteria:

• A flare-up of chronic pancreatitis

• End-stage chronic diseases (including pancreatic and bile duct cancer)

• Previous drainage or surgery for confirmed or suspected infected necrosis

• An acute intraabdominal event (e.g., perforation of a visceral organ, bleeding, or the abdominal compartment syndrome)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute
• Pancreatitis

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of sTREM-1 in fine needle aspiration fluid	The fluid level of sTREM-1 was used to diagnose the secondary infection of necrotic tissues in severe acute pancreatitis and select the proper treatment between single drainage and necrosectomy.	more than 14 days after entry	No
Secondary	The fluid level of Interleukin-6	The fluid level of Interleukin-6 was used to diagnose the secondary infection of necrotic tissues in severe acute pancreatitis and select the proper treatment between single drainage and necrosectomy.	more than 14 days after entry	No
Secondary	The fluid level of tumor necrosis factor-a	The fluid level of tumor necrosis factor-a was used to diagnose the secondary infection of necrotic tissues in severe acute pancreatitis and select the proper treatment between single drainage and necrosectomy.	more than 14 days after entry	No
Secondary	The serum level of sTREM-1	The serum level of sTREM-1 was used to diagnose the secondary infection of necrotic tissues in severe acute pancreatitis and select the proper treatment between single drainage and necrosectomy.	more than 14 days after entry	No
Secondary	The serum level of C-reactive protein	The serum level of C-reactive protein was used to diagnose the secondary infection of necrotic tissues in severe acute pancreatitis and select the proper treatment between single drainage and necrosectomy.	more than 14 days after entry	No
Secondary	The level of leukocyte count and neutrophil percentage	The level of leukocyte count and neutrophil percentage was used to diagnose the secondary infection of necrotic tissues in severe acute pancreatitis and select the proper treatment between single drainage and necrosectomy.	more than 14 days after entry	No