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Pancreatitis, ChronicNCT01773031

Pancreatic Duct Evaluation in Autoimmune Pancreatitis: MR Pancreatography

An observational study of Pancreatitis, Chronic and Autoimmune Disease, run by Jae Ho Byun at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pancreatitis, Chronic, Autoimmune Disease
How many people
30 participants
Where
1 siteSouth Korea
Study dates
Jan 2013to Mar 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with probable autoimmune pancreatitis based on clinical and CT findings

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Division of Abdomen, Department of Radiology & Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

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

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.

Read the 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.

Keywords
Autoimmune pancreatitis, MR pancreatography
Medical subject headings
Pancreatitis, Chronic, Autoimmune Diseases, Autoimmune Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01773031
Study groupRoleWhat they receive
Autoimmune pancreatitisPatients with autoimmune pancreatitis based on clinical and CT findings

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scoring for visualization of the main pancreatic duct on 1.5 T and 3.0 T MRP

    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

    Measured: Outcome measure will be assessed after a week following MRP examination

Secondary outcomes (3)

  1. Signal-to-noise ratio of the main pancreatic duct on 1.5 T and 3.0 T MRP

    Measured: Outcome measure will be assessed after a week following MRP examination

  2. 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

    Measured: Outcome measure will be assessed after a week following MRP examination

  3. 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)

    Measured: Outcome measure will be assessed after a week following MRP examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01773031
Sponsor's protocol ID
AMC-2012-1756
Status last verified
Dec 2015
First submitted
15 Jan 2013
Last updated
30 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17182992

  • 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.

    PubMed 22228050

  • 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.

    PubMed 20467343

  • 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.

    PubMed 19692840

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatitis, Chronic and Autoimmune Disease, run by Jae Ho Byun at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01773031, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.

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