PancreatitisNCT03937323
Immun Status at Pancreatitis Patients
An observational study of Pancreatitis and Immune Suppression, run by Istanbul Training and Research Hospital at 4 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Immune Suppression
- What is being tested?
- Blood lymphocyte subtypes and serum cytokines
- How many people
- 80 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Jul 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with biliary pancreatitis will be classified into three subgroups according to Apache classification and also Healthy Volunteers will be control group.
Who may be able to join
- 18-80 years old
- Diagnosis of acute biliary pancreatitis
- Sign the voluntary consent form
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Istanbul Traininng and Research Hospital
Istanbul, 34371
Hisar Hospital Intercontinental
Istanbul
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul
Yeditepe University
Istanbul
About this study
Official title: Immun Parameters and Flow Cytometry at Pancreatitis Patients
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.
Read the 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.
- Conditions
- Pancreatitis, Immune Suppression
- Being tested
- Blood lymphocyte subtypes and serum cytokines
- Keywords
- Pancreatitis, Lymphocyte subtypes, Cytokine
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pancreatitis group | Patients with biliary pancreatitis Receives: Other: Blood lymphocyte subtypes and serum cytokines | |
| Group 2: Control group, | Healthy volunteers Receives: Other: Blood lymphocyte subtypes and serum cytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
PD1,PDL1
To determine percent of PD1 and PDL1 on T lymphocytes and monocytes with Flow-Cytometry
Measured: 1 day
Secondary outcomes (1)
Cytokines
To determineof IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1, IL-6, IL -8, IL-10, IL-12p (p70), IL-17A, IL-18, IL-,23 and IL-33 values with Flow cytometry
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Istanbul Training and Research Hospital
- Investigators
- Ufuk Oguz Idiz, Assoc. Prof, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937323
- Sponsor's protocol ID
- Pancreatitis immun status
- Status last verified
- Jul 2020
- First submitted
- 2 May 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the editors want to see our data we can share
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.
PubMed 28174597Yang 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.
PubMed 25938229Li 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.
PubMed 25493006
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immun Parameters and Flow Cytometry at Pancreatitis Patients
- ClinicalTrials.gov ID
- NCT03937323
- Acronym / sponsor ID
- Pancreatitis immun status
- Conditions
- Pancreatitis, Immune Suppression
- Keywords
- Pancreatitis, Lymphocyte subtypes, Cytokine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pancreatitis group | – | Other: Blood lymphocyte subtypes and serum cytokinesPatients with biliary pancreatitis |
| Group 2: Control group, | – | Other: Blood lymphocyte subtypes and serum cytokinesHealthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biliary pancreatitis will be classified into three subgroups according to Apache classification and also Healthy Volunteers will be control group.
Key inclusion criteria (3 listed)
- 18-80 years old
- Diagnosis of acute biliary pancreatitis
- Sign the voluntary consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood lymphocyte subtypes and serum cytokinesBlood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine the proinflammatory cytokines | Other | Group 1: Pancreatitis group, Group 2: Control group, |
Primary outcome
Lymphocyte and monocyte subtypes
Time frame: 1 day
To determine T lymphocyte subtypes with Flow-Cytometry; T helper (CD4) (%) T cytotoxic (CD8) (%) NK cells (%) Classical monocytes Intermediate monocytes Non- Classical Monocytes
PD1,PDL1
Time frame: 1 day
To determine percent of PD1 and PDL1 on T lymphocytes and monocytes with Flow-Cytometry
1 secondary outcome
Cytokines
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 28174597Wang 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.
- Background: PubMed 25938229Yang 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.
- Background: PubMed 25493006Li 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.
- Individual participant dataSharing planned: Undecided. If the editors want to see our data we can share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ufuk Oguz Idiz, Assoc. Prof principal investigator
Istanbul Training and Research Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis and Immune Suppression, run by Istanbul Training and Research Hospital at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte and monocyte subtypes (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937323, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.