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Completed

NCT Number: NCT02616705

Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

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.

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Key information

Conditions

IgG4-related Sclerosing Cholangitis Autoimmune Diseases IgG4-related Disease Immune System Diseases Immunoglobulin G4-Related Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya City Universty Graduate School of Medical Sciences, Nagoya, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Nagoya University

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2015
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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