Pancreatic Cyst Follow-up study

Pancreatic Cyst Follow-up, an International Collaboration, PACYFIC study A prospective evaluation of pancreatic cyst surveillance, based on the consensus statement, formulated by the European study group on cystic tumours of the pancreas

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27080

Enrollment

5000

Registered

2014-04-10

Start date

2014-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cysts Follow-up Pancreatic cystic neoplasms

Interventions

Cyst surveillance will be performed at the hospital of origin, based on the recommendations of the consensus statement. Patients will be followed every 6 to 12 months by imaging studies (preferably Ma

Eligibility

Inclusion criteria

Inclusion criteria: • Individuals with a pancreatic cyst (either newly or previously diagnosed) • Cyst surveillance is warranted, according to the treating physician • Age >18 • Informed consent

Exclusion criteria

Exclusion criteria: • History of chronic pancreatitis • Suspected pseudocyst • Suspected serous cystadenoma • Von Hippel-Lindau disease • Limited life expectancy (< 2 years)

Design outcomes

Primary

Measure	Time frame
Primary outcomes are: the number of patients that reach an indication for surgical cyst resection and the number of patients diagnosed with a malignant cyst (either high-grade dysplasia or carcinoma).	—

Secondary

Measure	Time frame
Secondary outcomes are: 1. the outcome of patients with an indication for cyst resection; i.e. the number of operated patients, surgical procedures, morbidity, mortality, and cyst recurrence 2. cyst evolution, in terms of development of symptoms, cyst growth, nodules, and secondary pancreatic duct dilatation 3. the perceived burden of surveillance on participants. 4. possible risk factors for malignancy, either patient or cyst related 5. to build a micro-simulation screening analysis (MISCAN) model, based on the outcome data of this study, in order to determine the optimal strategy for pancreatic cyst surveillance.	—

Measure

Time frame

Secondary outcomes are: 1. the outcome of patients with an indication for cyst resection; i.e. the number of operated patients, surgical procedures, morbidity, mortality, and cyst recurrence 2. cyst evolution, in terms of development of symptoms, cyst growth, nodules, and secondary pancreatic duct dilatation 3. the perceived burden of surveillance on participants. 4. possible risk factors for malignancy, either patient or cyst related 5. to build a micro-simulation screening analysis (MISCAN) model, based on the outcome data of this study, in order to determine the optimal strategy for pancreatic cyst surveillance.

—

Contacts

Public ContactP.A. Riet, van

Erasmus University Medical Center

p.vanriet@erasmusmc.nl0031-107031635

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)