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.
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 Type
OBSERVATIONAL
Enrollment
511
Mayo Clinic
Rochester, Minnesota, United States
Nagoya City Universty Graduate School of Medical Sciences
Nagoya, Japan
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
Time frame: 2 year
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
Time frame: 2 years
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