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van CCT (UK)

van CCT (UK)

Pancreatic Cyst Follow-up study

- candidate number17332
- NTR NumberNTR4505
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-apr-2014
- Secondary IDsMEC-2014-021 METC Erasmus University Medical Center Rotterdam
- Public TitlePancreatic Cyst Follow-up study
- Scientific TitlePancreatic 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
- hypothesisTo establish the yield of pancreatic cyst surveillance, based on the recently published European consensus statement, and to identify possible alternative, more (cost) effective, surveillance strategies.
- Healt Condition(s) or Problem(s) studiedFollow-up, Surveillance, Pancreatic cysts
- 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 History of chronic pancreatitis
Suspected pseudocyst
Suspected serous cystadenoma
Von Hippel-Lindau disease
Limited life expectancy (< 2 years)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2014
- planned closingdate1-mei-2024
- Target number of participants5000
- InterventionsCyst 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 Magnetic Resonance Imaging (MRI/MRCP), with endoscopic ultrasonography (EUS) as an alternative) and determination of serum CA 19.9 levels. Both treating physicians and participating subjects will provide outcome data, by filling out (on-line) case record forms (CRF) and questionnaires. Cyst management will remain in the hands of the treating physician.
- Primary outcomePrimary 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 outcomeSecondary 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.
- TimepointsThe study will run for ten years.
Patients inclusion will be included from May 2014 until October 2023.
Follow-up will continue until April 2024.
The first analysis will be conducted in May 2017, after three years, to provide data for the MISCAN model.
- Trial web
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryThe aim of the PACYFIC study is to establish the yield of regular pancreatic cyst surveillance, based on a recently published European Consensus statement, in terms of identified patients that require cyst resection, diagnosed malignancies, cyst evolution, and the perceived burden for participants. As a result, possible alternative, more (cost) effective, surveillance strategies may be identified. All patients with a pancreatic cyst, either newly or previously diagnosed, that require surveillance according to the opinion of the treating physician, will be included. Surveillance will be based on the consensus statement, but at the discretion of the treating physician. Participating subjects will be asked to fill out online an questionnaire regarding the burden of surveillance after each follow-up visit. The study will be implemented in several international centers in Europe.
- Main changes (audit trail)
- RECORD10-apr-2014 - 1-mei-2014

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