Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts

NCT ID: NCT04473794

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2036-08-01

Brief Summary

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.

Conditions

Pancreatic Neoplasms; Pancreas Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elham Afghani, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elham Afghani, MD MPH

Role: CONTACT

eafghan1@jhmi.edu

410-614-6708

Facility Contacts

Elham Afghani, MD MPH

Role: primary

eafghan1@jhmi.edu

410-614-6708

Vaishnavi S Sawant, MBBS MPH

Role: backup

vsawant1@jh.edu

443-603-5875

Other Identifiers

IRB00249790

Identifier Type: -

Identifier Source: org_study_id