Pancreatic Duct Evaluation in Autoimmune Pancreatitis: MR Pancreatography

Autoimmune Disease Clinical Trial

Official title:

Pancreatic Duct Evaluation in Autoimmune Pancreatitis: Intraindividual Comparison of MR Pancreatography at 3.0 T and 1.5 T

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773031
• Other study ID #: AMC-2012-1756
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: December 28, 2015
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

A prospective intra-individual study to compare the image quality of magnetic resonance (MR) pancreatography at 3.0 T and 1.5 T in patients with autoimmune pancreatitis.

Description:

Autoimmune pancreatitis (AIP) is a unique form of chronic pancreatitis caused by an autoimmune mechanism that responds well to steroid therapy. One of the most important issues on AIP is to distinguish it from pancreatic cancer as the treatments are totally different from each other. An accurate differentiation of AIP from pancreatic cancer is therefore crucial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Typical CT findings (diffuse sausage-like pancreatic swelling or multifocal pancreatic swelling with or without peripancreatic rim, multifocal biliary stricture, renal lesion, or retroperitoneal fibrosis)

• Serum level of immunoglobulin G fraction 4 > 135mg/dL

Exclusion Criteria:

• Patients under 20 years of age

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Jae Ho Byun	Guerbet

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Finkelberg DL, Sahani D, Deshpande V, Brugge WR. Autoimmune pancreatitis. N Engl J Med. 2006 Dec 21;355(25):2670-6. Review. — View Citation

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 Jan 5. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoring for visualization of the main pancreatic duct on 1.5 T and 3.0 T MRP	Scoring for overall visualization of the main pancreatic duct (MPD): 1-4 points (1, entirely invisible; 2, faintly and partially visible; 3, faintly but entirely visible/clearly but partially visible; 4, clearly and entirely visible); Scoring for visualization of MPD stricture: 1-4 points (1, invisible; 2, poorly visible; 3, moderately visible; 4, clearly visible); Reference standard: ERP	Outcome measure will be assessed after a week following MRP examination	No
Secondary	Signal-to-noise ratio of the main pancreatic duct on 1.5 T and 3.0 T MRP		Outcome measure will be assessed after a week following MRP examination	No
Secondary	The rate of concordance in the stricture type of the main pancreatic duct between MRP and ERP	Stricture type of the main pancreatic duct: 1, diffuse; 2, segmental; 3, focal; 4, multifocal	Outcome measure will be assessed after a week following MRP examination	No
Secondary	Scoring for confidence in diagnosing AIP based on MRP findings	Scoring for confidence: 1-4 points (1, low probability; 2, indeterminate probability; 3, moderate probability; 4, high probability)	Outcome measure will be assessed after a week following MRP examination	No