- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01193413
Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis (STREM-1)
Soluble Triggering Receptor Expressed on Myeloid Cells in Severe Acute Pancreatitis: a Marker of Infected Necrosis and Indicator of Treatment
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Shanghai, Cina, 200433
- Changhai Hospital, Second Military Medical University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
---|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The level of sTREM-1 in fine needle aspiration fluid
Lasso di tempo: 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.
|
more than 14 days after entry
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The fluid level of Interleukin-6
Lasso di tempo: 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.
|
more than 14 days after entry
|
The fluid level of tumor necrosis factor-α
Lasso di tempo: 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.
|
more than 14 days after entry
|
The serum level of sTREM-1
Lasso di tempo: 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.
|
more than 14 days after entry
|
The serum level of C-reactive protein
Lasso di tempo: 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.
|
more than 14 days after entry
|
The level of leukocyte count and neutrophil percentage
Lasso di tempo: 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.
|
more than 14 days after entry
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Zhaoshen Li, MD, Changhai Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Changhai-100829
- 30772138 (Altro numero di sovvenzione/finanziamento: National Natural Science Foundation of China)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .