Immun Status at Pancreatitis Patients

• ClinicalTrials.gov Identifier: NCT03937323
• Recruitment Status: Completed
• First Posted: May 3, 2019
• Last Update Posted: July 21, 2020
• Sponsor: Istanbul Training and Research Hospital
• Information provided by (Responsible Party): Ufuk Oguz Idiz, Istanbul Training and Research Hospital

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 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 80 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
• Actual Primary Completion Date: June 1, 2020
• Actual Study Completion Date: July 1, 2020

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Turkey

Istanbul Traininng and Research Hospital

Istanbul, Turkey, 34371

Sponsors and Collaborators

Istanbul Training and Research Hospital

Investigators

• Principal Investigator: Ufuk Oguz Idiz, Assoc. Prof; Istanbul Training and Research Hospital

More Information

Publications:

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.

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.

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. Review.

• 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
• Last Update Posted: July 21, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: If the editors want to see our data we can share

• 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:

Pancreatitis; Pancreatic Diseases; Digestive System Diseases