Branch duct intraductal papillary mucinous neoplasm (BD-IPMN) Pancreatic cyst
Conditions
Interventions
Surveillance will be discontinued. 
Sponsors
Amsterdam UMC
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: Oral and written i nformed consentAge =70 yearsBD IPMN with =1 dilated branch duct(s) communicating with a nondilated main pancreatic duct (=5 millimeter) a s seen on Magnetic Resonance Cholangio Pancreatography (MRCP) MRCP), performed within the last 3 months prior to inclusion;At least 5 years of follow up prior to inclusion;Absence of relative and absolute indications for surgery at diagnosis and inclusion according to European guidelines;Absence of worrisome features and/or high risk stigmata at diagnosis and inclusion according to IAP guidelines;Cyst size =30 millimeters.
Exclusion criteria
Exclusion criteria: Personal or familial history of pancreatic cancerHistory of pancreatic surgeryWithdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is PC, including IPMN-derived PC, high grade dysplasia (HGD) or concurrent PC, confirmed by pathology (e.g., surgery, fine needle biopsy), and futile surgery at 5 years follow-up. Concurrent PC is defined as invasive PC that develops independently from the associated IPMN, with a non-dilated, segment of the pancreatic duct present between the two lesions [13, 14]. Therefore, a clear distinction will be made on what type of PC occurred (i.e., IPMN-derived, HGD, concurrent PC). Futile surgery is defined as surgery for IPMN with low-grade dysplasia confirmed at final pathology, or other non-malignant diagnosis (i.e., pseudocysts, serous cystadenoma). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include PC related mortality, all-causes mortality, time to progression or surgery (in months), incidence of low-grade and high-grade dysplasia at pathology, incidence of individual worrisome and high-risk features and of individual relative and absolute indications, incidence of pancreatic surgery, serum CA 19.9 value in U/L, cyst growth (mm/year), adjusted Charlson comorbidity index (ACCI) at diagnosis and at 5 years, rate of misdiagnosis (only in resected patients), incidence of additional follow-up and diagnostic work-up, and the incidence of symptoms suspect for PC during follow-up. | — |
Countries
Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United States
Contacts
Public ContactJ Schuitema
Amsterdam UMC
Outcome results
None listed