PancreatitisNCT04502940
Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?
An observational study of Pancreatitis and Lymphocytic Infiltrate, run by Istanbul Training and Research Hospital at 2 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, Lymphocytic Infiltrate, Immune System Diseases
- What is being tested?
- Flow Cytometric analysis
- How many people
- 53 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 29 Apr 2021
- 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 acute pancreatitis
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
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Training and Research Hospital
Istanbul, 34098
Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi
Istanbul, 34900
About this study
Official title: Can we Measure Pancreatitis Severity With Flow Cytometry?
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.
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.Treg cells are reported to be an independent prognostic factor in determining the severity of acute pancreatitis. 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 with lymphocyte subtypes via Flow-cytometry.
- Conditions
- Pancreatitis, Lymphocytic Infiltrate, Immune System Diseases
- Being tested
- Flow Cytometric analysis
- Keywords
- pancreatitis, lymphocyte, Flow-cytometry
- Medical subject headings
- Pancreatitis, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Mild pancreatitis | Patients with mild acute biliary pancreatitis according to Atlanta classification Receives: Diagnostic Test: Flow Cytometric analysis | |
| Moderate Pancreatitis | Patients with moderate acute biliary pancreatitis according to Atlanta classification Receives: Diagnostic Test: Flow Cytometric analysis | |
| Severe pancreatitis | Patients with severe acute biliary pancreatitis according to Atlanta classification Receives: Diagnostic Test: Flow Cytometric analysis | |
| Control | Healthy volunteers Receives: Diagnostic Test: Flow Cytometric analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte subtypes 1
T helper (CD4) (%)
Measured: 9 months
Lymphocyte subtypes 2
T cytotoxic (CD8) (%)
Measured: 9 months
Lymphocyte subtypes 3
Treg (CD25 and CD127) (%)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jun 2020
- Primary completion1 Apr 2021
- Study completion29 Apr 2021
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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oguzkagan Batikan, Istanbul Training and Research Hospital
- Investigators
- Oguzhagan Batikan, M.D., Principal investigator, İstanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502940
- Sponsor's protocol ID
- Pancreatitis 01.06.2020
- Status last verified
- Apr 2021
- First submitted
- 4 Aug 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Measure Pancreatitis Severity With Flow Cytometry?
- ClinicalTrials.gov ID
- NCT04502940
- Acronym / sponsor ID
- Pancreatitis 01.06.2020
- Conditions
- Pancreatitis, Lymphocytic Infiltrate, Immune System Diseases
- Keywords
- pancreatitis, lymphocyte, Flow-cytometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 6 Aug 2020 (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 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.Treg cells are reported to be an independent prognostic factor in determining the severity of acute pancreatitis. 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 with lymphocyte subtypes via Flow-cytometry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild pancreatitis | – | Diagnostic Test: Flow Cytometric analysisPatients with mild acute biliary pancreatitis according to Atlanta classification |
| Moderate Pancreatitis | – | Diagnostic Test: Flow Cytometric analysisPatients with moderate acute biliary pancreatitis according to Atlanta classification |
| Severe pancreatitis | – | Diagnostic Test: Flow Cytometric analysisPatients with severe acute biliary pancreatitis according to Atlanta classification |
| Control | – | Diagnostic Test: Flow Cytometric analysisHealthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute pancreatitis
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 |
|---|---|---|
| Flow Cytometric analysisBlood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine lymphocyte subgroups | Diagnostic test | Control, Mild pancreatitis, Moderate Pancreatitis, Severe pancreatitis |
Primary outcome
Lymphocyte subtypes 1
Time frame: 9 months
T helper (CD4) (%)
Lymphocyte subtypes 2
Time frame: 9 months
T cytotoxic (CD8) (%)
Lymphocyte subtypes 3
Time frame: 9 months
Treg (CD25 and CD127) (%)
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 3 May 2021.
- 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
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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.
Oguzhagan Batikan, M.D. principal investigator
İstanbul Training and Research Hospital
2 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 Lymphocytic Infiltrate, run by Istanbul Training and Research Hospital at 2 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 subtypes 1 (time frame: 9 months). The study lists 3 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 NCT04502940, 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 3 May 2021.