Pancreatic Duct Evaluation in Autoimmune Pancreatitis: MR Pancreatography

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Asan Medical Center
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Jae Ho Byun, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01773031
First received: January 15, 2013
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

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.


Condition
Pancreatitis, Chronic
Autoimmune Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pancreatic Duct Evaluation in Autoimmune Pancreatitis: Intraindividual Comparison of MR Pancreatography at 3.0 T and 1.5 T

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Scoring for confidence: 1-4 points (1, low probability; 2, indeterminate probability; 3, moderate probability; 4, high probability)


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Autoimmune pancreatitis
Patients with autoimmune pancreatitis based on clinical and CT findings

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with probable autoimmune pancreatitis based on clinical and CT findings

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773031

Contacts
Contact: Jae Ho Byun, MD, PhD 82-2-3010-4387 jhbyun@amc.seoul.kr
Contact: Jin Hee Kim, MD 82-2-3010-5390 kimjhrad@amc.seoul.kr

Locations
Korea, Republic of
Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jae Ho Byun, MD, PhD    82-2-3010-4387    jhbyun@amc.seoul.kr   
Principal Investigator: Jae Ho Byun, MD, PhD         
Sponsors and Collaborators
Jae Ho Byun
Guerbet
Investigators
Principal Investigator: Jae Ho Byun, MD, PhD University of Ulsan College of Medicine, Asan Medical Center
  More Information

Publications:
Responsible Party: Jae Ho Byun, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01773031     History of Changes
Other Study ID Numbers: AMC-2012-1756
Study First Received: January 15, 2013
Last Updated: January 26, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Autoimmune pancreatitis
MR pancreatography

Additional relevant MeSH terms:
Autoimmune Diseases
Pancreatitis
Pancreatitis, Chronic
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014