Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?

Completed

• Conditions: Immune System Diseases; Lymphocytic Infiltrate; Pancreatitis

• Registration Number: NCT04502940
• 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 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.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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Status Verified: 2021-04
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-29
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Primary Outcome Measures

Name	Time	Method
Lymphocyte subtypes 1	9 months	T helper (CD4) (%)
Lymphocyte subtypes 3	9 months	Treg (CD25 and CD127) (%)
Lymphocyte subtypes 2	9 months	T cytotoxic (CD8) (%)

Trial Locations

Locations (2)

İstanbul Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey