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OpenTrials
Completed

NCT Number: NCT04502940

Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flow Cytometric analysis

Diagnostic Test

Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine lymphocyte subgroups

Primary outcomes

  1. Lymphocyte subtypes 1

    Time frame: 9 months

    T helper (CD4) (%)

  2. Lymphocyte subtypes 2

    Time frame: 9 months

    T cytotoxic (CD8) (%)

  3. Lymphocyte subtypes 3

    Time frame: 9 months

    Treg (CD25 and CD127) (%)

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

Can we Measure Pancreatitis Severity With Flow Cytometry?

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2020
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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