Clinical Trial: Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Bile Usefulness for Detecting 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 Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA. [ Time Frame: 2 year ]

Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods


Original Primary Outcome: Same as current

Current Secondary Outcome: Correlation between bile and serum IgG4 concentrations. [ Time Frame: 2 years ]

The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: November 23, 2015
Date Started: November 2015
Date Completion: November 2016
Last Updated: September 12, 2016
Last Verified: September 2016