Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Completed

• Conditions: IgG4-related Sclerosing Cholangitis; IgG4-related Disease

• Registration Number: NCT02616705
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Nagoya City Universty Graduate School of Medical Sciences; 🇯🇵 Nagoya, Japan