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临床试验/NCT04502940
NCT04502940已完成不适用

Can we Measure Pancreatitis Severity With Flow Cytometry?

Istanbul Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
2
主要终点
Lymphocyte subtypes 1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 years old
  • Diagnosis of acute biliary pancreatitis
  • Sign the voluntary consent form

排除标准

  • 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

结局指标

主要结局

Lymphocyte subtypes 1

时间窗: 9 months

T helper (CD4) (%)

Lymphocyte subtypes 3

时间窗: 9 months

Treg (CD25 and CD127) (%)

Lymphocyte subtypes 2

时间窗: 9 months

T cytotoxic (CD8) (%)

次要结局

未报告次要终点

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Oguzkagan Batikan

Principal Investigator

Istanbul Training and Research Hospital

研究点 (2)

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