PACYFIC
Research type
Research Study
Full title
Pancreatic Cyst Follow-up, an International Collaboration
IRAS ID
215859
Contact name
Stephen Pereira
Contact email
Sponsor organisation
Erasmus University Medical Centre
Duration of Study in the UK
7 years, 6 months, 1 days
Research summary
Asymptomatic pancreatic cysts are a common finding in this time of elaborate imaging. The malignant potential of these cysts is probably small, but exact data regarding cancer risks are limited. In 2013, a group of European experts formulated a consensus statement, recommending lifelong follow-up with MRI, every 6 to 12 months. This strategy may be justified for some individuals, to timely detect malignant progression, but in the majority of cases, cysts will never progress. Consequently, these patients are likely to undergo lifelong redundant (and costly) investigations.
The objective of this study is to establish the yield of pancreatic cyst surveillance, based on the recently published European experts consensus statement, and to identify possible alternative, more (cost) effective, surveillance strategies.
This is an international multicentre observational cohort study that will run for 10 years. The first analysis will take place after three years.
The study population will be patients with a pancreatic cyst that requires surveillance.
The treating physician at the hospital will perform cyst surveillance. Patients will be followed every 6 to 12 months by imaging studies (EUS/MRI/MRCP) 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.
The Primary endpoints 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 endpoints are: 1. outcome of patients with an indication for cyst resection 2. cyst evolution, in terms of development of symptoms and cyst growth 3. the perceived burden of surveillance on participants. 4. possible risk factors for malignancy 5. 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.REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/1016
Date of REC Opinion
20 Jun 2018
REC opinion
Favourable Opinion