Pancreatic cysts Pancreascysten
Conditions
Interventions
Patients who are planned to undergo surveillance with MRI/MRCP will undergo 3.0T MRI/MRCP with contrast (gadovist) instead of 1.5T MRI/MRCP with gadovist. Imaging features of 3.0T MRI/MRCP and previo
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: ‐ Patients with one or more pancreatic cysts (≥ 1 cm) ‐ ≥ 18 years old ‐ Previous 1.5T MRI/MRCP within 2 years of inclusion ‐ Written informed consent
Exclusion criteria
Exclusion criteria: ‐ Clear or likely connection between the cyst and the PD on previous 1.5T MRI/MRCP ‐ Clear imaging, biochemical and/or cytological features of serous/mucinous cystic neoplasms (i.e. honeycomb-like cyst, central scar, large unilocular cyst or Carcinoembryonic antigen (CEA) < 5). ‐ Medical history of chronic pancreatitis ‐ Any contraindication for MRI according to local guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the number of patients in whom a connection between the pancreatic cyst and PD can be visualized with increased certainty on 3.0T compared with 1.5T MRI/MRCP, evaluated by an experienced radiologist using a 5-point scale: 1: no connection PD 2: unlikely connection PD 3: undetermined connection PD 4: likely connection PD 5: clear connection PD | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in follow-up or treatment strategy according to the current guidelines (International Association of Pancreatology (IAP) and European Cystic Tumor Study Group. 2. Visualization of worrisome features with 3.0T compared with 1.5T MRI/MRCP: ‐ Mural nodules ‐ Thickened/enhancing cyst walls 3. Difference in cyst morphology on 3.0T compared with 1.5T MRI/MRCP: ‐ Lobulation ‐ Pleomorphism 4. Amount of artefacts, evaluated by using a 3-point scale: - 1: artefacts causing difficulties evaluating images - 2: minor/moderate artefacts without diagnostic relevance - 3: (almost) no artefacts 5. Interobserver agreement: intraclass correlation coefficient (ICC) values higher than 0.8 are considered to be excellent concordance, values between 0.6 and 0.8 as good, values between 0.4 and 0.6 as moderate, values between 0.2 and 0.4 as fair and values below 0.2 as poor | — |
Contacts
Public ContactS. Lekkerkerker
Dept. of Gastroenterology and Hepatology Academic Medical Center Meibergdreef 9, C2-310
Outcome results
None listed