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

Follow-up of immunoglobulin G4-associated cholangitis in patients resected for presumed perihilar cholangiocarcinoma - IgG4 follow-up after biliary surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42948

Enrollment

Registered

2016-07-20

Start date

2016-10-05

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autoimmune cholangitis IgG4-associated cholangitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: not applicable

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results