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Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02616705
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : July 7, 2020
Nagoya University
Information provided by (Responsible Party):
Lewis R. Roberts, Mayo Clinic

Brief Summary:
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 or disease
IgG4-related Sclerosing Cholangitis IgG4-related Disease

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
Study Start Date : November 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

IgG4-related sclerosing cholangitis
Patients with IgG4-related sclerosing cholangitis (also called IgG4 associated cholangitis, IgG4 related cholangitis, or biliary IgG4-related disease)
cholangiocarcinoma, PSC, and other patients with biliary strictures

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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
  • Unable to collect a bile sample
  • Abnormal postsurgical anatomy preventing collection of a bile sample

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02616705

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Contact: Lewis R Roberts, M.B., Ch.B., Ph.D. 507-266-3239
Contact: Katsuyuki Miyabe, M.D., Ph.D. 507-538-4877

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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lewis R Roberts, M.B., Ch.B., Ph.D.    507-266-3239   
Nagoya City Universty Graduate School of Medical Sciences Recruiting
Nagoya, Japan
Contact: Itaru Naito, MD, PhD    81-52-553-8211   
Sponsors and Collaborators
Mayo Clinic
Nagoya University
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Principal Investigator: Lewis R Roberts, M.B., Ch.B., Ph.D. Mayo Clinic
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Responsible Party: Lewis R. Roberts, Principal Investigator, Mayo Clinic Identifier: NCT02616705    
Other Study ID Numbers: 15-004819
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing could be arranged and will require IRB approval
Additional relevant MeSH terms:
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Cholangitis, Sclerosing
Immunoglobulin G4-Related Disease
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Autoimmune Diseases
Immune System Diseases