Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis

NCT01193413 | Completed DMC

• 2 other identifiers: Changhai-10082930772138
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute; Pancreatitis

Keywords

acute pancreatitis; Drainage; Pancreatic surgery; Biological Markers/analysis; Infection diagnosis; ROC Curve; Sensitivity and Specificity; Endoscopic ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• The fluid level of Interleukin-6

  more than 14 days after entry

• The fluid level of tumor necrosis factor-α

  more than 14 days after entry

• The serum level of sTREM-1

  more than 14 days after entry

• The serum level of C-reactive protein

  more than 14 days after entry

• The level of leukocyte count and neutrophil percentage

  more than 14 days after entry

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

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.

MeSH Terms

Conditions

Pancreatitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Immune System Diseases

Study Officials

• zhaoshen li, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 2, 2010
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 2, 2010

Record last verified: 2009-09

Locations

CN (1)