Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?

NCT ID: NCT04502940

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-04-29

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.

Conditions

Pancreatitis; Lymphocytic Infiltrate; Immune System Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Mild pancreatitis

Patients with mild acute biliary pancreatitis according to Atlanta classification

Flow Cytometric analysis

Intervention Type: 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

Moderate Pancreatitis

Patients with moderate acute biliary pancreatitis according to Atlanta classification

Flow Cytometric analysis

Intervention Type: 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

Severe pancreatitis

Patients with severe acute biliary pancreatitis according to Atlanta classification

Flow Cytometric analysis

Intervention Type: 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

Control

Healthy volunteers

Flow Cytometric analysis

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Oguzkagan Batikan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oguzhagan Batikan, M.D.

Role: PRINCIPAL_INVESTIGATOR

İstanbul Training and Research Hospital

Locations

İstanbul Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28174597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25938229 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25493006 (View on PubMed)

Other Identifiers

Pancreatitis 01.06.2020

Identifier Type: -

Identifier Source: org_study_id