Immun Status at Pancreatitis Patients

Completed

• Conditions: Pancreatitis; Immune Suppression
• Interventions: Other: Blood lymphocyte subtypes and serum cytokines

• Registration Number: NCT03937323
• Lead Sponsor: Istanbul Training and Research Hospital

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.

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-06-01
• Primary Completion: 2020-06-01
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Control group,	Blood lymphocyte subtypes and serum cytokines	Healthy volunteers
Group 1: Pancreatitis group	Blood lymphocyte subtypes and serum cytokines	Patients with biliary pancreatitis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Hisar Hospital Intercontinental; 🇹🇷 Istanbul, Turkey

Istanbul Traininng and Research Hospital; 🇹🇷 Istanbul, Turkey

Sisli Hamidiye Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Yeditepe University; 🇹🇷 Istanbul, Turkey