Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

NCT ID: NCT02616705

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

511 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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IgG4-related Sclerosing Cholangitis IgG4-related Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IgG4-related sclerosing cholangitis

Patients with IgG4-related sclerosing cholangitis (also called IgG4 associated cholangitis, IgG4 related cholangitis, or biliary IgG4-related disease)

No interventions assigned to this group

Controls

cholangiocarcinoma, PSC, and other patients with biliary strictures

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagoya University

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Lewis R. Roberts

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lewis R Roberts, MB, ChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Nagoya City Universty Graduate School of Medical Sciences

Nagoya, , Japan

Site Status

Countries

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United States Japan

Related Links

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Other Identifiers

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15-004819

Identifier Type: -

Identifier Source: org_study_id

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