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Immun Status at Pancreatitis Patients

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ClinicalTrials.gov Identifier: NCT03937323
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ufuk Oguz Idiz, 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 serum proinflammatory cytokines with ELISA and lymphocyte subtypes with Flow-cytometry.


Condition or disease Intervention/treatment
Pancreatitis Immune Suppression Other: Blood lymphocyte subtypes and serum cytokines

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. It was reported that inflammatory markers, especially anti-inflammatory IL-10 levels were elevated in patients with acute pancreatitis, and CRP and IL-1β levels of inflammatory markers were higher in patients with organ failure. Treg cells are reported to be an independent prognostic factor in determining the severity of acute pancreatitis. There is only one study with a limited number of patients in whom PD-1 values in T lymphocytes and PD-L1 values in monocytes were determined in the literature. In this study, it is stated that PD-L1 can be used as a new marker in determining infectious complications. 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 and serum proinflammatory cytokines with ELISA and lymphocyte subtypes with Flow-cytometry.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Immun Parameters and Flow Cytometry at Pancreatitis Patients
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort Intervention/treatment
Group 1: Pancreatitis group
Patients with biliary pancreatitis
Other: Blood lymphocyte subtypes and serum cytokines
Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine the proinflammatory cytokines

Group 2: Control group,
Healthy volunteers
Other: Blood lymphocyte subtypes and serum cytokines
Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine the proinflammatory cytokines




Primary Outcome Measures :
  1. Lymphocyte subtypes [ Time Frame: 1 day ]
    To determine T lymphocyte subtypes with Flow-Cytometry; T helper (CD4) (%) T cytotoxic (CD8) (%) Regulator T cells (CD127) (%)

  2. PD1,PDL1 [ Time Frame: 1 day ]
    To determine percent of PD1 and PDL1 on T lymphocytes and monocytes with Flow-Cytometry


Secondary Outcome Measures :
  1. Cytokines [ Time Frame: 1 day ]
    To determine IL1, IL10, TNF- alfa values with ELISA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with biliary pancreatitis will be classified into three subgroups according to Apache classification and also Healthy Volunteers will be control group.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937323


Contacts
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Contact: Ufuk Oguz Idiz, Assoc. Prof +905062044714 oguzidiz@yahoo.com

Locations
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Turkey
Istanbul Traininng and Research Hospital Recruiting
Istanbul, Turkey, 34371
Contact: Ufuk Oguz Idiz, Assoc. Prof.    05062044714    oguzidiz@yahoo.com   
Sponsors and Collaborators
Istanbul Training and Research Hospital
Investigators
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Principal Investigator: Ufuk Oguz Idiz, Assoc. Prof Istanbul Training and Research Hospital
Publications:
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Responsible Party: Ufuk Oguz Idiz, Principal Investigator, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03937323    
Other Study ID Numbers: Pancreatitis immun status
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If the editors want to see our data we can share

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ufuk Oguz Idiz, Istanbul Training and Research Hospital:
Pancreatitis
Lymphocyte subtypes
Cytokine
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases