Immun Status at Pancreatitis Patients

NCT03937323 — Completed, 80 participants, Istanbul Training and Research Hospital

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Immun Parameters and Flow Cytometry at Pancreatitis Patients

RegistryNCT03937323
StatusCompleted
Study typeObservational
Enrollment80 (Actual)
SponsorIstanbul Training and Research Hospital (Other gov)
ConditionsPancreatitis, Immune Suppression
InterventionsBlood lymphocyte subtypes and serum cytokines (Other)
Datesstart 2019-06-01, primary completion 2020-06-01, completion 2020-07-01, first posted 2019-05-03, last updated 2023-05-06
Locations4 sites in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Pancreatitis All trials for Immune Suppression All trials of Blood lymphocyte subtypes and serum cytokines

-Summary

Pancreatitis is a common complication especially in patients with gallbladder stones, most patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20% of patients, the disease is severe and mortality rates of up to 30% are detected in these patients. In the evaluation of acute biliary pancreatitis, many scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity and mortality of the disease.

In this study, the investigators aimed to evaluate the correlation between morbidity and mortality of acute biliary pancreatitis and serum proinflammatory cytokines with ELISA and lymphocyte subtypes with Flow-cytometry.

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+Detailed description

Pancreatitis is a common complication especially in patients with gallbladder stones, most patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20% of patients, the disease is severe and mortality rates of up to 30% are detected in these patients. In patients with severe pancreatitis, aggressive fluid replacement, organ damage follow-up, appropriate antibiotherapy, and endoscopic sphincterotomy and radiological interventions may be of great benefit. In the evaluation of acute biliary pancreatitis, many scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity and mortality of the disease. There are limited number of studies in the literature about the immune parameters in the evaluation of acute pancreatitis. In a studies, serum inflammatory markers such as IL-1, IL-6 and CD4, CD8 T lymphocyte and Treg population were evaluated. It was reported that inflammatory markers, especially anti-inflammatory IL-10 levels were elevated in patients with acute pancreatitis, and CRP and IL-1β levels of inflammatory markers were higher in patients with organ failure. Treg cells are reported to be an independent prognostic factor in determining the severity of acute pancreatitis. There is only one study with a limited number of patients in whom PD-1 values in T lymphocytes and PD-L1 values in monocytes were determined in the literature. In this study, it is stated that PD-L1 can be used as a new marker in determining infectious complications. In patients diagnosed with acute biliary pancreatitis, determination of the course of the disease at the time of diagnosis is extremely important for treatment and survival.

In this study, the investigators aimed to evaluate the correlation between morbidity and mortality of acute biliary pancreatitis and serum proinflammatory cytokines with ELISA and lymphocyte subtypes with Flow-cytometry.

+Arms and interventions

ArmTypeInterventionsDescription
Group 1: Pancreatitis groupOther: Blood lymphocyte subtypes and serum cytokinesPatients with biliary pancreatitis
Group 2: Control group,Other: Blood lymphocyte subtypes and serum cytokinesHealthy volunteers
  • Blood lymphocyte subtypes and serum cytokines (Other): Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine the proinflammatory cytokines

+Outcome measures

Primary outcomes

  • Lymphocyte and monocyte subtypes [1 day]: To determine T lymphocyte subtypes with Flow-Cytometry; T helper (CD4) (%) T cytotoxic (CD8) (%) NK cells (%) Classical monocytes Intermediate monocytes Non- Classical Monocytes
  • PD1,PDL1 [1 day]: To determine percent of PD1 and PDL1 on T lymphocytes and monocytes with Flow-Cytometry

Secondary outcomes

  • Cytokines [1 day]: To determineof IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1, IL-6, IL -8, IL-10, IL-12p (p70), IL-17A, IL-18, IL-,23 and IL-33 values with Flow cytometry

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

* 18-80 years old
* Diagnosis of acute biliary pancreatitis
* Sign the voluntary consent form

Exclusion Criteria:

* Being under 18 or older than 80
* Not signing the voluntary consent form
* Pancreatitis resulting from an interventional procedure (ERCP, surgery, etc.)
* Pregnant women
* Being a history of immunodeficiency
* Cancer history

+Locations (4)

FacilityCityCountryStatus
Istanbul Traininng and Research HospitalIstanbulTurkey (Türkiye)
Hisar Hospital IntercontinentalIstanbulTurkey (Türkiye)
Sisli Hamidiye Etfal Training and Research HospitalIstanbulTurkey (Türkiye)
Yeditepe UniversityIstanbulTurkey (Türkiye)

+Publications

  • Wang W, Xiang HP, Wang HP, Zhu LX, Geng XP. CD4 + CD25 + CD127 high cells as a negative predictor of multiple organ failure in acute pancreatitis. World J Emerg Surg. 2017 Feb 2;12:7. doi: 10.1186/s13017-017-0116-7. eCollection 2017. PMID 28174597
  • Yang Z, Zhang Y, Dong L, Yang C, Gou S, Yin T, Wu H, Wang C. The Reduction of Peripheral Blood CD4+ T Cell Indicates Persistent Organ Failure in Acute Pancreatitis. PLoS One. 2015 May 4;10(5):e0125529. doi: 10.1371/journal.pone.0125529. eCollection 2015. PMID 25938229
  • Li J, Yang WJ, Huang LM, Tang CW. Immunomodulatory therapies for acute pancreatitis. World J Gastroenterol. 2014 Dec 7;20(45):16935-47. doi: 10.3748/wjg.v20.i45.16935. PMID 25493006

+Investigators