Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

IgG4-related Disease Clinical Trial

Official title:

Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616705
• Other study ID #: 15-004819
• Status: Completed
• Start date: November 2015
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• IgG4-related Disease
• IgG4-related Sclerosing Cholangitis

Locations

Country	Name	City	State
Japan	Nagoya City Universty Graduate School of Medical Sciences	Nagoya
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Nagoya University

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.	Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods	2 year
Secondary	Correlation between bile and serum IgG4 concentrations.	The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods	2 years

External Links

•   Mayo Clinic Clinical Trials