To 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.
ID
Bron
Verkorte titel
Aandoening
Pancreatic cysts
Follow-up
Pancreatic cystic neoplasms
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
To 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.
Onderzoeksopzet
The 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.
Onderzoeksproduct en/of interventie
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 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.
Publiek
P.A. Riet, van
Rotterdam
The Netherlands
0031-107031635
p.vanriet@erasmusmc.nl
Wetenschappelijk
P.A. Riet, van
Rotterdam
The Netherlands
0031-107031635
p.vanriet@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Individuals with a pancreatic cyst (either newly or previously diagnosed)
• Cyst surveillance is warranted, according to the treating physician
• Age >18
• Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• History of chronic pancreatitis
• Suspected pseudocyst
• Suspected serous cystadenoma
• Von Hippel-Lindau disease
• Limited life expectancy (< 2 years)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4365 |
NTR-old | NTR4505 |
Ander register | METC Erasmus University Medical Center Rotterdam : MEC-2014-021 |