Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis

NCT ID: NCT01193413

Last Updated: 2010-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-11-30

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.

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.

Conditions

Acute; Pancreatitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-infected necrosis group

There is no necrosis infection in severe acute pancreatitis.

No interventions assigned to this group

Single drainage group

The patients with necrosis infection in severe acue pancreatitis were cured by single drainage.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Changhai Hospital, Second Military Medical University

Principal Investigators

zhaoshen li, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hospital, Second Military Medical University

Shanghai, , China

Countries

China

Other Identifiers

30772138

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Changhai-100829

Identifier Type: -

Identifier Source: org_study_id