Follow-up of immunoglobulin G4-associated cholangitis in patients resected for presumed perihilar cholangiocarcinoma

Completed

• Conditions: autoimmune cholangitis; IgG4-associated cholangitis; 10019654

• Registration Number: NL-OMON42948
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

- Patient underwent resection for presumed PHC at the AMC between 1984 and May 2016
- Histological assessment revealed a benign (sclerosing) tumor
- Patient is alive according to the municipal records database

Exclusion Criteria

not applicable

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Histological assessment of resection specimens by an experienced pathologist<br /><br>according to diagnostic consensus criteria for IAC. The combination of >10<br /><br>IgG4+ B cells/high-power field plus two out of the three following histological<br /><br>criteria is considered highly suggestive of IAC:<br /><br>- Lymphoplasmacytic infiltration<br /><br>- Storiform (*cartwheel* or *mat-like*) fibrosis<br /><br>- Obliterative phlebitis<br /><br>2) Confirmation of diagnosis of IAC by laboratory assessment of IgG4 RNA and<br /><br>protein levels.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Evaluation of diagnostic accuracy of the histological criteria for IAC<br /><br>2) Evaluation of disease activity by laboratory assessment, including:<br /><br>- Chemistry: ASAT, ALAT, alkaline phosphatase, gamma-GT, total bilirubin,<br /><br>CA19-9, total IgG.<br /><br>- Immunology: IgG subclasses.<br /><br>3) Screening of serum for auto-antibodies</p><br>