Clinical trial NCT03937323: Immun Status at Pancreatitis Patients
Official title: Immun Parameters and Flow Cytometry at Pancreatitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Immune Suppression
Keywords: Pancreatitis
Lymphocyte subtypes
Cytokine
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biliary pancreatitis will be classified into three subgroups according to Apache classification and also Healthy Volunteers will be control group.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lymphocyte and monocyte subtypes
timeFrame: 1 day
measure: PD1,PDL1
timeFrame: 1 day
Secondary outcomes:
measure: Cytokines
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Traininng and Research Hospital
city: Istanbul
country: Turkey
facility: Hisar Hospital Intercontinental
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Ufuk Oguz Idiz, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.