To identify new means to improve the differential diagnosis of pancreatic cystic lesions to guide patient management.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aims are to identify new means to improve the differential
diagnosis of pancreatic cystic lesions to guide patient management and to
assess the biological behaviour of the pancreatic cystic lesions.
Secondary outcome
To describe a large single-centre experience with pancreatic cystic lesions,
including presenting signs and symptoms and methods of diagnosis.
To assess the development and natural behaviour of pancreatic cysts according
to a predefined follow-up scheme/ regimen.
To identify new biomarkers of pancreatic cystic neoplasms using proteomics
technology and assess their feasibility and reliability compared to well-known
tumor markers and enzymes for pathological diagnosis in patients with a
pancreatic cystic lesion.
To make recommendations for the accurate diagnosis and optimal treatment of
patients with all types of pancreatic cystic lesions.
Background summary
An increasing number of asymptomatic individuals with pancreatic cystic lesions
are being identified because of a more frequent use of sophisticated abdominal
imaging techniques. Cystic lesions of the pancreas comprise of a heterogeneous
group of diagnostic entities, some of which are (virtually) benign such as
inflammatory pseudocyst or serous cystadenoma and, when asymptomatic, do not
require surgical resection. Others have a malignant potential (mucinous cystic
neoplasms or intraductal papillary mucinous neoplasms (IPMN)) and in these
cases surgical resection is indicated. Because of pre-operative difficulties in
characterizing the nature of pancreatic cystic lesions and a cautious
management strategy based on the policy not to withhold a patient from a
rightly indicated resection (pre-malignant and malignant lesions), many
asymptomatic people with truly benign lesions undergo surgery as a consequence.
Therefore, adequate distinction between the various types of pancreatic cystic
lesions should allow for a better selection of patients to prevent patients
with truly benign lesions to be exposed to unnecessary surgery with associated
morbidity and mortality. Techniques that potentially could be of value in the
differentiation include radiologic imaging techniques (MR, viscosity/density
measurements, endosonography) and the use of new biomarkers including
proteomics technology.
Study objective
To identify new means to improve the differential diagnosis of pancreatic
cystic lesions to guide patient management.
Study design
This prospective protocol will incorporate various investigational techniques
such as MR scan, EUS and EUS-FNA (fluid sampling including brush cytology). The
value of the various imaging techniques will assessed by linking imaging
features to the clinical outcome (surgery, follow-up). EUS will be the main
device in order to assess cystic changes and perform follow-up. Additionally,
MR will be used to measure the viscosity/density index of the lesions. Newly
developed EUS brush cytology devices will be used to obtain cytology from the
inner wall of the cyst to be analysed by means of conventional cytology and
EUS-FNA will be employed to sample cyst fluid for biochemical and biomarker
assessment including the use of proteomics.
Study burden and risks
Main burden of participation is the initially 6-monthly follow-up in which the
subject undergoes repeated endosonographic investigations and blood sampling,
which both are considered low-risk interventions. Major benefits might occur
when a subject doesn*t have to undergo extensive pancreatic surgery, when this
turns to be unnecessary.
Meibergdreef 9
1105 AZ, Amsterdam
Nederland
Meibergdreef 9
1105 AZ, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Cystic lesion on cross-sectional imaging (percutaneous ultrasound and/or CT scan and/or MR scan)
Suspicion of a pancreatic neoplasm
Exclusion criteria
Acute phase of an acute pancreatitis
PT-INR>1.5, PTT>50, trombocytes<50.000
Synchronic malign neoplasm in stomach / colon / rectum / lung / breast / liver
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 | NL14139.018.06 |