Skip to content

The Biliary Bicarbonate Umbrella in Fibrosing Cholangiopathies

The Biliary Bicarbonate Umbrella in Fibrosing Cholangiopathies - The Bicarbonate Umbrella

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54354
Enrollment
450
Registered
2020-06-23
Start date
2021-11-30
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

(1) cholestatic liver diseases (2) fibrosing cholangiopathies

Interventions

The only additional procedure that subjects will undergo is bile aspiration during ERCP. The ERCP endoscope will be equipped with a 5-French catheter that is inserted through an existing channel i

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * * 18 years of age * Already planned to undergo one of the following elective procedures: endoscopic retrograde cholangiopancreatography, percutaneous transhepatic cholangiography with drainage of the bile ducts, liver biopsy, segmental liver resection, Whipple procedure, pylorus preserving pancreaticoduodenectomy * Diagnosed with either: primary sclerosing cholangitis, primary biliary cholangitis, lgG4-Related Disease, pancreatitis, liver metastasis of primary coloncarcinoma, choledocholithiasis, liveradenoma, suspected pancreatic tumour, cholangiocarcinoma * able to provide informed consent

Exclusion criteria

Exclusion criteria: Pregnancy Clinically unstable patients (as assessed by treating physician) Patients admitted to the ICU

Design outcomes

Primary

MeasureTime frame
To determine the structure, composition and function of the biliary HCO3- umbrella in cholangioids and liver biopsies derived from fibrosing cholangiopathy subjects compared to non-fibrosing cholangiopathy subjects.

Secondary

MeasureTime frame
1. Compare the effects of potentially therapeutic agents such as UDCA conjugates, norUDCA, FXR agonists and fibrates on the biliary HCO3- umbrella in order to protect cholangioids against the malicious effects of toxic bile acids.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)