Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Neoplasms, Pancreas Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The aims of this study are to determine the natural history of pancreatic cysts and 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.
Detailed description
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, including imaging and standard laboratory data, to accurately and reliably discriminate neoplastic from non-neoplastic, and benign from malignant cysts, particularly in patients without symptoms. Therefore, some patients with benign cysts undergo unnecessary costly surveillance and possible avoidable surgical resections, which is associated with high cost, significant morbidity and mortality, while some may not be as aggressively followed. 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). (1) Although these guidelines emphasize the frequency of surveillance and outline the indications for resection, these guidelines have not yet been validated, and these guidelines 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 malignancy. Hence, there is a critical need for a diagnostic model that more accurately diagnoses neoplastic mucinous and malignant pancreatic cysts as this will improve the management of many patients with pancreatic cysts.
Primary outcome measures
- Clinical utility of Compcyst in pancreatic cysts as assessed by patient chart review [Time frame: 15 years]
Eligibility criteria
Inclusion criteria
- Adult patients age 18 years and older
- Referred for assessment of a pancreatic cyst.
Exclusion criteria
- Medically ill patients with American Society of Anesthesiologists class 4 or greater.
- Inability to provide informed consent.
- Pregnancy or lactation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- The Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT04473794 · IRB00249790