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Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Mayo Clinic
Sponsor:
Collaborator:
Nagoya University
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02616705
First received: November 23, 2015
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.

Condition
IgG4-related Sclerosing Cholangitis
IgG4-related Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA. [ Time Frame: 2 year ]
    Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods


Secondary Outcome Measures:
  • Correlation between bile and serum IgG4 concentrations. [ Time Frame: 2 years ]
    The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods


Biospecimen Retention:   None Retained
Bile

Estimated Enrollment: 300
Study Start Date: November 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
IgG4-related sclerosing cholangitis
Patients with IgG4-related sclerosing cholangitis (also called IgG4 associated cholangitis, IgG4 related cholangitis, or biliary IgG4-related disease)
Controls
cholangiocarcinoma, PSC, and other patients with biliary strictures

Detailed Description:
This study will recruit cases from Mayo Clinic Rochester and Japanese institutions such as Nagoya City University Hospital, Nagoya Daini Red Cross Hospital, and Kurashiki Central hospital. Participants will be individuals who will receive endoscopic retrograde cholangiography (ERC), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or percutaneous transhepatic cholangiography (PTC). Bile samples collected from the target cases will be assayed for IgG4 concentration.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cases with biliary stricture(s) of any cause
Criteria

Inclusion Criteria:

  • The presence of a biliary stricture
  • 18 years and older
  • Consented to IRB 707-03

Exclusion Criteria:

  • Younger than 18 years of age
  • Unsuccessful inability to collect a bile sample
  • Abnormal postsurgical anatomy preventing collection of a bile sample
  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: NCT02616705

Contacts
Contact: Mark D. Topazian, M.D. 507-26-6931 Topazian.Mark@mayo.edu
Contact: Katsuyuki Miyabe, M.D., Ph.D. 507-538-4877 miyabe.katsuyuki@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark D. Topazian, M.D.    507-266-6931    Topazian.Mark@mayo.edu   
Japan
Nagoya City Universty Graduate School of Medical Sciences Recruiting
Nagoya, Japan
Contact: Itaru Naito, MD, PhD    81-52-553-8211    inaito@mad.nagoya-cu.ac.jp   
Sponsors and Collaborators
Mayo Clinic
Nagoya University
Investigators
Principal Investigator: Mark D. Topazian, M.D. Mayo Clinic
  More Information

Responsible Party: Mark Topazian, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02616705     History of Changes
Other Study ID Numbers: 15-004819
Study First Received: November 23, 2015
Last Updated: September 12, 2016
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Data sharing could be arranged and will require IRB approval

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017