Pancreatic Duct Evaluation in Autoimmune Pancreatitis: MR Pancreatography
NCT ID: NCT01773031
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2013-01-31
2015-03-31
Brief Summary
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Detailed Description
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Two most important image findings of AIP are pancreatic enlargement and pancreatic ductal stricture. When CT shows typical diffuse sausage-like swelling of the pancreas and peripancreatic hypodense rim, it is easy to differentiate AIP from pancreatic cancer. However, those typical cases are not very common and, moreover, 30% of AIP manifest as focal mass/enlargement of the pancreas, making a differential diagnosis very difficult. When pancreatic feature is atypical at CT, it is important to find diffuse or multifocal stricture of the main pancreatic duct that is characteristic feature of AIP. In AIP, a diffusely attenuated pancreatic duct is thinner than normal, and this does not appear at CT. Pancreatography is therefore necessary.
Two current imaging tools to demonstrate the pancreatic duct are endoscopic retrograde pancreatography (ERP) and MR pancreatography (MRP). ERP provides high resolution images using different projections and enables various procedures including aspiration/biopsy and stent insertion. However, the use of diagnostic ERP in diagnosing AIP has been debated as ERP is an invasive procedure, having potential complications including pancreatitis, perforation of the stomach or duodenum. Moreover, it is difficult to perform endoscopic procedure in patients who underwent gastric surgery. Whereas, MRP can noninvasively image the pancreatic and biliary systems at the same time without risks of procedure-related complications and can evaluate other intrabdominal organs on cross-sectional images. The relatively lower spatial resolution of MRP using 1.5 T compared with ERP images may make it difficult to demonstrate fine changes of the pancreatic duct in AIP and sometimes make false positive or negative findings.
The superiority of 3.0 T over 1.5 T MR systems has been observed in several studies. However, only a few studies using the 3.0 T MR systems in the pancreaticobiliary tract have been reported and, furthermore, the usefulness of 3.0 T MRP for the diagnosis of AIP has not yet been investigated.
The purpose of this study is to prospectively compare the image quality of MRP at 3.0 T and 1.5 T in patients with AIP using ERP as the reference standard.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Autoimmune pancreatitis
Patients with autoimmune pancreatitis based on clinical and CT findings
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Serum level of immunoglobulin G fraction 4 \> 135mg/dL
Exclusion Criteria
* Women who are pregnant, lactating or who are of childbearing potential
* Patients with any physical or mental status that interferes with the signing of informed consent
* Patients with a contraindication for MRP or ERP examination
20 Years
ALL
No
Sponsors
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Guerbet
INDUSTRY
Jae Ho Byun
OTHER
Responsible Party
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Jae Ho Byun
Associate Professor
Principal Investigators
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Jae Ho Byun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ulsan College of Medicine, Asan Medical Center
Locations
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Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, , South Korea
Countries
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References
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Finkelberg DL, Sahani D, Deshpande V, Brugge WR. Autoimmune pancreatitis. N Engl J Med. 2006 Dec 21;355(25):2670-6. doi: 10.1056/NEJMra061200. No abstract available.
Kim JH, Kim MH, Byun JH, Lee SS, Lee SJ, Park SH, Lee SK, Park DH, Lee MG, Moon SH. Diagnostic Strategy for Differentiating Autoimmune Pancreatitis From Pancreatic Cancer: Is an Endoscopic Retrograde Pancreatography Essential? Pancreas. 2012 May;41(4):639-647. doi: 10.1097/MPA.0b013e31823a509b. Epub 2012 Jan 5.
Park SH, Kim MH, Kim SY, Kim HJ, Moon SH, Lee SS, Byun JH, Lee SK, Seo DW, Lee MG. Magnetic resonance cholangiopancreatography for the diagnostic evaluation of autoimmune pancreatitis. Pancreas. 2010 Nov;39(8):1191-8. doi: 10.1097/MPA.0b013e3181dbf469.
Onishi H, Kim T, Hori M, Murakami T, Tatsumi M, Nakaya Y, Nakamoto A, Osuga K, Tomoda K, Nakamura H. MR cholangiopancreatography at 3.0 T: intraindividual comparative study with MR cholangiopancreatography at 1.5 T for clinical patients. Invest Radiol. 2009 Sep;44(9):559-65. doi: 10.1097/RLI.0b013e3181b4c0ae.
Other Identifiers
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AMC-2012-1756
Identifier Type: -
Identifier Source: org_study_id