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Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

NCT02616705 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 511

Last updated 2022-01-05

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Nagoya University

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Lewis R Roberts, MB, ChB, PhD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States
  • Japan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616705 on ClinicalTrials.gov