Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?

Pancreatitis Clinical Trial

Official title:

Can we Measure Pancreatitis Severity With Flow Cytometry?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502940
• Other study ID #: Pancreatitis 01.06.2020
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: April 29, 2021

Study information

• Verified date: April 2021
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 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.Treg cells are reported to be an independent prognostic factor in determining the severity of acute pancreatitis. 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 with lymphocyte subtypes via Flow-cytometry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 29, 2021
• Est. primary completion date: April 1, 2021
• 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 System Diseases
• Lymphocytic Infiltrate
• Pancreatitis

Intervention

Diagnostic Test:
• Flow Cytometric analysis
Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine lymphocyte subgroups

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Taksim Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Istanbul Training and Research Hospital	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. Review. — 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 subtypes 1	T helper (CD4) (%)	9 months
Primary	Lymphocyte subtypes 2	T cytotoxic (CD8) (%)	9 months
Primary	Lymphocyte subtypes 3	Treg (CD25 and CD127) (%)	9 months