The general aim is to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination of clinical, radiologic, and biomarker…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
benigne, premaligne en maligne neoplastische pancreascysten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To determine the proportion of patients with malignancy in operable
pancreatic cysts.
- To determine the sensitivity, specificity, and overall accuracy of imaging
(CT, MRI and EUS) in patients with pancreatic cysts.
- To determine the factors associated with malignancy in pancreatic cyst using
a multivariate model including clinical, radiologic, and molecular markers.
- To develop and prospectively validate a panel of molecular markers to
differentiate benign pancreatic cysts from those with malignant potential using
surgical pathology as the gold standard.
Secondary outcome
- To determine the proportion of IPMN based on molecular markers.
- To determine of the natural history of IPMN.
- To collect tissue samples (cyst fluid and blood) for research on molecular
markers in pancreatic cysts.
Background summary
Pancreatic cysts are increasingly recognized as incidental lesions due to the
widespread use of cross-sectional imaging techniques such as CT and MRI.
Twenty percent of all pancreatic cysts are non-inflammatory cystic neoplasms,
many of which are mucinous, and therefore have a significant potential for
malignant transformation. The primary challenge facing clinicians is the
inability of current standard diagnostic tests to accurately and reliably
discriminate neoplastic from non-neoplastic, and benign from malignant cysts,
particularly in patients without symptoms. Asymptomatic patients with
pancreatic cysts may be misdiagnosed and treated with unnecessary surgical
resection. The International Association of Pancreatology (IAP) has published
guidelines on the management of the two main types of mucinous cystic lesions:
intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic neoplasms
(MCNs) (Tanaka et al. 2012). Although these guidelines emphasize the frequency
of surveillance and outline the indications for resection, they have not yet
been validated, and they presume the diagnosis of a mucinous neoplastic cyst
has been confirmed prior to surgery. It is unlikely that guidelines that only
use clinical and imaging will be able to accurately differentiate benign cysts
from those that are pre-malignant or currently harbor cancer. Hence, there is a
critical need for a diagnostic model that more accurately diagnoses neoplastic
mucinous and malignant pancreatic cysts.
Study objective
The general aim is to propose and prospectively validate a diagnostic approach
and model for prediction of mucinous versus non-mucinous, and malignant versus
non-malignant, pancreatic cysts using a combination of clinical, radiologic,
and biomarker characteristics.
Study design
Prospective, multi-center study
Study burden and risks
There are no additional risks above those related to standard clinical care.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Adult patients age 18 years and older.
* Referred for assessment of a pancreatic cyst.
Exclusion criteria
* Medically ill patients with ASA class 4 or greater.
* Inability to provide informed consent.
* Pregnancy or lactation.
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 |
|---|---|
| ClinicalTrials.gov | NCT02110498 |
| CCMO | NL49988.018.14 |