Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02616705

Enrollment

511

Registered

2015-11-30

Start date

2015-11-30

Completion date

2019-09-30

Last updated

2022-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related Disease, IgG4-related Sclerosing Cholangitis

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.	2 year	Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods

Secondary

Measure	Time frame	Description
Correlation between bile and serum IgG4 concentrations.	2 years	The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods

Countries

Japan, United States

Outcome results