Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04502940
Collaborator
(none)
53
2
10.9
26.5
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Flow Cytometric analysis

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 Design

Study Type:
Observational
Actual Enrollment :
53 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Can we Measure Pancreatitis Severity With Flow Cytometry?
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Mild pancreatitis

Patients with mild acute biliary pancreatitis according to Atlanta classification

Diagnostic Test: 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

Moderate Pancreatitis

Patients with moderate acute biliary pancreatitis according to Atlanta classification

Diagnostic Test: 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

Severe pancreatitis

Patients with severe acute biliary pancreatitis according to Atlanta classification

Diagnostic Test: 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

Control

Healthy volunteers

Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

  1. Lymphocyte subtypes 1 [9 months]

    T helper (CD4) (%)

  2. Lymphocyte subtypes 2 [9 months]

    T cytotoxic (CD8) (%)

  3. Lymphocyte subtypes 3 [9 months]

    Treg (CD25 and CD127) (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul Training and Research Hospital Istanbul Turkey 34098
2 Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi Istanbul Turkey 34900

Sponsors and Collaborators

  • Istanbul Training and Research Hospital

Investigators

  • Principal Investigator: Oguzhagan Batikan, M.D., İstanbul Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Oguzkagan Batikan, Principal Investigator, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04502940
Other Study ID Numbers:
  • Pancreatitis 01.06.2020
First Posted:
Aug 6, 2020
Last Update Posted:
May 3, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oguzkagan Batikan, Principal Investigator, Istanbul Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2021