Immun Status at Pancreatitis Patients

Pancreatitis Clinical Trial

Official title:

Immun Parameters and Flow Cytometry at Pancreatitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937323
• Other study ID #: Pancreatitis immun status
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Suppression
• Pancreatitis

Intervention

Other:
• Blood lymphocyte subtypes and serum cytokines
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

Locations

Country	Name	City	State
Turkey	Hisar Hospital Intercontinental	Istanbul
Turkey	Istanbul Traininng and Research Hospital	Istanbul
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul
Turkey	Yeditepe University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphocyte and monocyte subtypes	To determine T lymphocyte subtypes with Flow-Cytometry; T helper (CD4) (%) T cytotoxic (CD8) (%) NK cells (%) Classical monocytes Intermediate monocytes Non- Classical Monocytes	1 day
Primary	PD1,PDL1	To determine percent of PD1 and PDL1 on T lymphocytes and monocytes with Flow-Cytometry	1 day
Secondary	Cytokines	To determineof IL-1ß, IFN-a2, IFN-?, TNF-a, MCP-1, IL-6, IL -8, IL-10, IL-12p (p70), IL-17A, IL-18, IL-,23 and IL-33 values with Flow cytometry	1 day