Clinical Trial: Pancreatic Duct Evaluation in Autoimmune Pancreatitis: MR Pancreatography

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:

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 int
Sponsor: Jae Ho Byun

Current Primary Outcome: Scoring for visualization of the main pancreatic duct on 1.5 T and 3.0 T MRP [ Time Frame: Outcome measure will be assessed after a week following MRP examination ]

  1. 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)

  2. Scoring for visualization of MPD stricture: 1-4 points (1, invisible; 2, poorly visible; 3, moderately visible; 4, clearly visible)

    • Reference standard: ERP


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Signal-to-noise ratio of the main pancreatic duct on 1.5 T and 3.0 T MRP [ Time Frame: Outcome measure will be assessed after a week following MRP examination ]
  • The rate of concordance in the stricture type of the main pancreatic duct between MRP and ERP [ Time Frame: Outcome measure will be assessed after a week following MRP examination ]
    Stricture type of the main pancreatic duct: 1, diffuse; 2, segmental; 3, focal; 4, multifocal
  • Scoring for confidence in diagnosing AIP based on MRP findings [ Time Frame: Outcome measure will be assessed after a week following MRP examination ]
    Scoring for confidence: 1-4 points (1, low probability; 2, indeterminate probability; 3, moderate probability; 4, high probability)


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: January 15, 2013
Date Started: January 2013
Date Completion:
Last Updated: December 28, 2015
Last Verified: December 2015