NCT03937323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 6, 2023

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

May 2, 2019

Last Update Submit

May 4, 2023

Conditions

PancreatitisImmune Suppression

Keywords

PancreatitisLymphocyte subtypesCytokine

Outcome Measures

Primary Outcomes (2)

  • Lymphocyte and monocyte subtypes

    To determine T lymphocyte subtypes with Flow-Cytometry; T helper (CD4) (%) T cytotoxic (CD8) (%) NK cells (%) Classical monocytes Intermediate monocytes Non- Classical Monocytes

    1 day

  • PD1,PDL1

    To determine percent of PD1 and PDL1 on T lymphocytes and monocytes with Flow-Cytometry

    1 day

Secondary Outcomes (1)

  • Cytokines

    1 day

Study Arms (2)

Group 1: Pancreatitis group

Patients with biliary pancreatitis

Other: Blood lymphocyte subtypes and serum cytokines

Group 2: Control group,

Healthy volunteers

Other: Blood lymphocyte subtypes and serum cytokines

Interventions

Blood lymphocyte subtypes and serum cytokinesOTHER

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 1: Pancreatitis groupGroup 2: Control group,

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • years old
  • Diagnosis of acute biliary pancreatitis
  • Sign the voluntary consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Istanbul Traininng and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Hisar Hospital Intercontinental

Istanbul, Turkey (Türkiye)

Location

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28174597BACKGROUND

  • 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.

    PMID: 25938229BACKGROUND

  • 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.

    PMID: 25493006BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Ufuk Oguz Idiz, Assoc. Prof

    Istanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 3, 2019

Study Start

June 1, 2019

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

May 6, 2023

Record last verified: 2020-07

Locations

TU(4)