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Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis (STREM-1)

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ClinicalTrials.gov Identifier: NCT01193413
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : September 2, 2010
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease
Acute Pancreatitis

Detailed 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.


Study Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis: a Marker of Infected Necrosis and Indicator of Treatment
Study Start Date : July 2008
Primary Completion Date : July 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Non-infected necrosis group
There is no necrosis infection in severe acute pancreatitis.
Single drainage group
The patients with necrosis infection in severe acue pancreatitis were cured by single drainage.
Combined surgery group
If there was no clinical improvement after single drainage about 7 days, an open necrosectomy was performed in the patients with necrosis infection.


Outcome Measures

Primary Outcome Measures :
  1. The level of sTREM-1 in fine needle aspiration fluid [ Time Frame: more than 14 days after entry ]
    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.


Secondary Outcome Measures :
  1. The fluid level of Interleukin-6 [ Time Frame: more than 14 days after entry ]
    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.

  2. The fluid level of tumor necrosis factor-α [ Time Frame: more than 14 days after entry ]
    The fluid level of tumor necrosis factor-α was used to diagnose the secondary infection of necrotic tissues in severe acute pancreatitis and select the proper treatment between single drainage and necrosectomy.

  3. The serum level of sTREM-1 [ Time Frame: more than 14 days after entry ]
    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.

  4. The serum level of C-reactive protein [ Time Frame: more than 14 days after entry ]
    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.

  5. The level of leukocyte count and neutrophil percentage [ Time Frame: more than 14 days after entry ]
    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.


Biospecimen Retention:   Samples Without DNA
The FNA fluid specimens were performed under ultrasound or CT guidance, using a 18G needle attached to a 15 ml eppendorf tube. One percent xylocaine was used for local anaesthesia. Under real-time visualization, the needle was directed into the tissue part of the necrosis or pseudocyst.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients 18 years of age or older who were hospitalized in our medical pancreatic intensive care unit (PICU) for least two weeks were enrolled in the study if there was a clinical suspicion of secondary infection of necrotic tissue.
Criteria

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)
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193413


Locations
China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
Principal Investigator: zhaoshen li, MD Changhai Hospital
More Information

Responsible Party: Zhaoshen Li, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT01193413     History of Changes
Other Study ID Numbers: Changhai-100829
30772138 ( Other Grant/Funding Number: National Natural Science Foundation of China )
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: September 2009

Keywords provided by Changhai Hospital:
acute pancreatitis
Drainage
Pancreatic surgery
Biological Markers/analysis
Infection diagnosis
ROC Curve
Sensitivity and Specificity
Endoscopic ultrasonography

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases