NCT04502940

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

August 4, 2020

Last Update Submit

April 30, 2021

Conditions

PancreatitisLymphocytic InfiltrateImmune System Diseases

Keywords

pancreatitislymphocyteFlow-cytometry

Outcome Measures

Primary Outcomes (3)

  • Lymphocyte subtypes 1

    T helper (CD4) (%)

    9 months

  • Lymphocyte subtypes 2

    T cytotoxic (CD8) (%)

    9 months

  • Lymphocyte subtypes 3

    Treg (CD25 and CD127) (%)

    9 months

Study Arms (4)

Mild pancreatitis

Patients with mild acute biliary pancreatitis according to Atlanta classification

Diagnostic Test: Flow Cytometric analysis

Moderate Pancreatitis

Patients with moderate acute biliary pancreatitis according to Atlanta classification

Diagnostic Test: Flow Cytometric analysis

Severe pancreatitis

Patients with severe acute biliary pancreatitis according to Atlanta classification

Diagnostic Test: Flow Cytometric analysis

Control

Healthy volunteers

Diagnostic Test: Flow Cytometric analysis

Interventions

Flow Cytometric analysisDIAGNOSTIC_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

ControlMild pancreatitisModerate PancreatitisSevere pancreatitis

Eligibility Criteria

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

Patients with acute pancreatitis

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 (2)

İstanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi

Istanbul, 34900, 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

PancreatitisImmune System Diseases

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Oguzhagan Batikan, M.D.

    İstanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 6, 2020

Study Start

June 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 29, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

TU(2)