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Comparison of 3.0T and 1.5T MRCP for the evaluation of pancreatic cysts


- candidate number22818
- NTR NumberNTR5449
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2015
- Secondary IDsW14_306 # 15.0264 METC AMC
- Public TitleComparison of 3.0T and 1.5T MRCP for the evaluation of pancreatic cysts
- Scientific TitleComparison of 3.0T and 1.5T MRCP for the evaluation of pancreatic cysts
- ACRONYMCOMPACT
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedPancreatic cysts
- 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‐ 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-sep-2015
- planned closingdate1-mei-2015
- Target number of participants20
- InterventionsPatients 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.
- Primary outcomePrimary 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 outcome1. 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
- TimepointsOne 3.0T MRI/MRCP will be made during routine follow-up.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Lekkerkerker
- CONTACT for SCIENTIFIC QUERIES S. Lekkerkerker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Investigator initiated trial ( IIT )
- Publications
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD1-sep-2015 - 22-nov-2015


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