The objective of the study is to investigate the long-term clinical outcome of AIP with a minimum follow-up of two years.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the prevalence of exocrine and endocrine insufficiency in AIP
patients.
Secondary outcome
To evaluate the following aspects of long-term outcome in AIP patients:
i. Mortality and cause of death
ii. Treatment over time: steroids, other drugs, response and relapses
iii. Extrapancreatic manifestations of AIP/IgG4-related disease
iv. Malignancy
v. Morphology (including changes over time in case multiple imaging sets are
available) of the pancreas on imaging
vi. Quality of life
Background summary
Autoimmune pancreatitis (AIP) is a distinct type of chronic pancreatitis (CP),
which predominantly affects males in their fifth and sixth decades. AIP
presents clinically as obstructive jaundice and less frequent with steatorrhea,
diabetes mellitus and various extrapancreatic manifestations. This disease has
several characteristic radiological features including diffuse enlargement of
the pancreas and irregular narrowing of the main pancreatic duct which may be
present but are not obligatory. Laboratory tests often reveal elevated serum
levels of IgG, IgG4 and the presence of autoantibodies, but not in all cases.
Steroids have to shown to be a highly effective therapy for AIP.4, 7-9 However,
following steroid tapering or cessation, relapses are observed frequently
(6-55%).10-12
Inflammation of the pancreas during an extended period can result in
substantial fibrosis of the pancreas, causing permanent damage. This is
frequently resulting in endocrine and/or exocrine insufficiency of the
pancreas.
Until now, long-term outcome has been described in relatively small series with
a limited follow-up period. Especially the outcome with focus on pancreatic
exocrine and endocrine function has been scarcely described in only
retrospective series which are presumably subject to bias.
Study objective
The objective of the study is to investigate the long-term clinical outcome of
AIP with a minimum follow-up of two years.
Study design
This is a prospective, cross-sectional study.
Study burden and risks
Burden:
Participation in this study requires withdrawal of blood and collection of a
small amount of feces, both will take place once. The withdrawal of blood can
take place during a routine visit at the attending gastroenterologist, so the
subject will not have to travel far. If the patient does not have an
appointment with the attending gastroenterologist, the principal investigator
can visit the patient at home to withdraw the blood sample.
Feces will be send by mail, in a box which will be sent to the subject by us.
The subject will be asked to complete 2 questionaires concerning quality of
life, and 1 questionaire concerning the course of the disease (AIP). This will
take 1-1.5 hours. The questionaires will be send by mail, including a
self-adressed envelope, with which the subject can return the questionaires.
Risks:
Withdrawal of blood can result in little pain, swelling and/or infection or a
bruise. The collection of feces is not related with any risk.
Dr. Molewaterplein 50-60
Rotterdam 3015 CE
NL
Dr. Molewaterplein 50-60
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
The following patients are eligible for the study:
• All patients diagnosed with AIP according to the ICDC, Asian or HISORT criteria or based on post-surgery histology, a combination of unexplained pancreatic disease, biliary disease/extrapancreatic manifestations and either response to steroids or IgG4-positive serology.
•At least known for more than 2 years with a diagnosis of AIP
•Age > 18 years
•Signed informed consent
Exclusion criteria
The following patients are excluded from the study:
•Subjects who are unwilling or unable to understand the study and sign the informed consent.
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 | NL41656.078.12 |