AcuteSTREM-1NCT01193413
Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis
An observational study of Acute and Pancreatitis, run by Changhai Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute, Pancreatitis
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis: a Marker of Infected Necrosis and Indicator of Treatment
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.
Read the 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
- Keywords
- acute pancreatitis, Drainage, Pancreatic surgery, Biological Markers/analysis, Infection diagnosis, ROC Curve, Sensitivity and Specificity, Endoscopic ultrasonography
- Medical subject headings
- Pancreatitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: more than 14 days after entry
Secondary outcomes (5)
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.
Measured: more than 14 days after entry
The fluid level of tumor necrosis factor-α
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.
Measured: more than 14 days after entry
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.
Measured: more than 14 days after entry
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.
Measured: more than 14 days after entry
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.
Measured: more than 14 days after entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcuteStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- zhaoshen li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193413
- Sponsor's protocol ID
- Changhai-100829
- Other IDs
- 30772138
- Acronym
- STREM-1
- Status last verified
- Sep 2009
- First submitted
- 30 Aug 2010
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis: a Marker of Infected Necrosis and Indicator of Treatment
- ClinicalTrials.gov ID
- NCT01193413
- Acronym / sponsor ID
- STREM-1 / Changhai-100829
- Conditions
- Acute, Pancreatitis
- Keywords
- acute pancreatitis, Drainage, Pancreatic surgery, Biological Markers/analysis, Infection diagnosis, ROC Curve, Sensitivity and Specificity, Endoscopic ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
The fluid level of Interleukin-6
Time frame: more than 14 days after entry
The fluid level of tumor necrosis factor-α
Time frame: more than 14 days after entry
The serum level of sTREM-1
Time frame: more than 14 days after entry
The serum level of C-reactive protein
Time frame: more than 14 days after entry
The level of leukocyte count and neutrophil percentage
Time frame: more than 14 days after entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhaoshen li, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute and Pancreatitis, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of sTREM-1 in fine needle aspiration fluid (time frame: more than 14 days after entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2010.