NCT01773031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

2.2 years

First QC Date

January 15, 2013

Last Update Submit

December 28, 2015

Conditions

Pancreatitis, ChronicAutoimmune Disease

Keywords

Autoimmune pancreatitisMR pancreatography

Outcome Measures

Primary Outcomes (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

    Outcome measure will be assessed after a week following MRP examination

Secondary Outcomes (3)

  • 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

  • The rate of concordance in the stricture type of the main pancreatic duct between MRP and ERP

    Outcome measure will be assessed after a week following MRP examination

  • Scoring for confidence in diagnosing AIP based on MRP findings

    Outcome measure will be assessed after a week following MRP examination

Study Arms (1)

Autoimmune pancreatitis

Patients with autoimmune pancreatitis based on clinical and CT findings

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with probable autoimmune pancreatitis based on clinical and CT findings

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 138-736, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 17182992BACKGROUND

  • 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.

    PMID: 22228050BACKGROUND

  • 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.

    PMID: 20467343BACKGROUND

  • 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.

    PMID: 19692840BACKGROUND

MeSH Terms

Conditions

Pancreatitis, ChronicAutoimmune DiseasesAutoimmune Pancreatitis

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Jae Ho Byun, MD, PhD

    University of Ulsan College of Medicine, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 23, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

KR(1)