The primary aim is to explore the system-wide leukocyte composition in order to identify and quantify immune subsets in patients with alcoholic, biliary and idiopathic AP. Secondary we aim to identify subsets prognostic for the severity of the…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are immune subsets which consist of a clustering of
peripheral blood leukocytes.
Secondary outcome
Secondary study parameters include serum urea, CRP, leukocyte counts,
mortality, morbidity, days of admission, prognostic scores, medical history,
medication, alcohol and drug use.
Background summary
Acute pancreatitis (AP) is an inflammation of the pancreas with a mild disease
course in 80% and severe course in 20% of the patients.1 Common causes of AP
include chronic alcohol abuse or biliary stones, other causes include, but are
not limited to, post-ERCP and idiopathic disease. Until now, studies into
leukocytes in early AP have associated an increase in neutrophils with a more
severe disease course. Yet, a more detailed assessment of major immune lineages
is lacking. We hypothesize that patients with alcoholic, biliary and idiopathic
AP have a specific composition of immune lineages and that immune subsets can
be a prognostic tool to predict the severity of the disease course.
Study objective
The primary aim is to explore the system-wide leukocyte composition in order to
identify and quantify immune subsets in patients with alcoholic, biliary and
idiopathic AP. Secondary we aim to identify subsets prognostic for the severity
of the disease course.
Study design
Observational study
Study burden and risks
Participating patients will be subjected to one extra blood draw (four tubes,
24 mL). In addition the study coordinator will have access to the medical chart
of the patient. The medical treatment of participants is not different,
participants will not be reimbursement.
de Boelelaan 1118
Amsterdam 1081HZ
NL
de Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
Patients
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Suspected acute biliary, alcoholic or idiopathic pancreatitis
At least 2 out of 3 criteria of acute pancreatitis:
- Pain in upper abdomen
- Serum amylase and/or lipase >3x upper limit of normal (ULN)
- Signs of acute pancreatitis on CT or MR
* 18 years old
Provide informed consent;Healthy volunteers
A person is eligible to participate as healthy volunteer if they are considered to be healthy and if their age and gender matches with a patient included in this study.
Exclusion criteria
Use of medications with possible immune-modulating effects (e.g., steroids or recent chemotherapy)
Time from onset of abdominal pain to hospital admission >48 hours
Established diagnosis of chronic pancreatitis
Suspected cholangitis;Healthy volunteers
Use of medications with possible immune-modulating effects (e.g., steroids or recent chemotherapy)
Current or recent (in the last two weeks) infectious disease (i.e. influenza)
Systemic diseases
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65443.029.18 |