We hypothesize that 3.0T MRI/MRCP might be more accurate in visualizing a connection between a pancreatic cyst and the PD than 1.5T MRI/MRCP.
ID
Bron
Verkorte titel
Aandoening
Pancreatic cysts
Pancreascysten
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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:<br>
1: no connection PD <br>
2: unlikely connection PD<br>
3: undetermined connection PD<br>
4: likely connection PD<br>
5: clear connection PD
Achtergrond van het onderzoek
Rationale: Distinction between the different types of pancreatic cysts is crucial, since some cysts are benign without need for follow-up, whereas others are premalignant and require either surgical resection or surveillance. A key feature of the most common premalignant cyst, the side branch-intraductal papillary mucinous neoplasm (SB-IPMN), is the presence of a connection between the cyst and the pancreatic duct (PD). Current imaging, mostly done with 1.5T MRI/MRCP, is often not capable of visualizing this connection. Recent, small studies have suggested that 3.0T MRI/MRCP can provide superior image quality with improved delineation of the PD, but prospective studies in patients with pancreatic cysts are lacking. We hypothesize that 3.0T MRI/MRCP might be more accurate in visualizing a connection between a pancreatic cyst and the PD than 1.5T MRI/MRCP.
Objective: Primary objective is to compare the diagnostic ability of 3.0T and 1.5T MRI/MRCP in visualizing PD communication of pancreatic cysts. Second objectives are to compare the presence of mural nodules and thickened cyst wall and the amount of artefacts.
Study design: Prospective consecutive cohort of 20 patients.
Study population: Consecutive adult patients of the multidisciplinary pancreatic cyst clinic who are under follow-up for at least one pancreatic cyst in which no clear or likely connection with the PD has been seen on previous 1.5T MRI/MRCP and without classic features of a serous/mucinous cystic neoplasm.
Intervention: 3.0T MRI/MRCP during routine follow up of pancreatic cysts
Main study parameters/endpoints: Primary endpoint is the number of patients in whom a connection between the pancreatic cyst and PD can be visualized with 3.0T, whereas 1.5T MRI/MRCP could not.
Doel van het onderzoek
We hypothesize that 3.0T MRI/MRCP might be more accurate in visualizing a connection between a pancreatic cyst and the PD than 1.5T MRI/MRCP.
Onderzoeksopzet
One 3.0T MRI/MRCP will be made during routine follow-up.
Onderzoeksproduct en/of interventie
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 previously made 1.5T MRI/MRCP will be compared.
Publiek
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Wetenschappelijk
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
‐ 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
‐ 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
Opzet
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