This is a randomized, open-label, controlled, parallel group, multicenter clinical trial. Patients with confirmed secondary sclerosing cholangitis (SSC-CIP) will be randomized either in the intervention group undergoing scheduled invasive evaluation of the biliary tract or in the control group treated with non-interventional standard of care to demonstrate that programmed endoscopic therapy compared to a conservative strategy reduces the occurrence of treatment failures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
invasive evaluation of the biliary tract with ERC and endoscopic interventions every 8 weeks until 6 months (24 weeks)
Hannover Medical School
Hanover, Lower Saxony, Germany
occurrence of death
The primary endpoint is the failure rate defined as a composite endpoint consisting of * occurrence of death or * necessity of liver transplantation or * occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.
Time frame: up to week 48
necessity of liver transplantation
The primary endpoint is the failure rate defined as a composite endpoint consisting of * occurrence of death or * necessity of liver transplantation or * occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.
Time frame: up to week 48
occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.
The primary endpoint is the failure rate defined as a composite endpoint consisting of * occurrence of death or * necessity of liver transplantation or * occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.
Time frame: up to week 48
Laboratory parameters (bilirubin in µmol/L) as change from baseline
Time frame: week 24
Laboratory parameters (alkaline phosphatase in U/L) as change from baseline
Time frame: week 24
Laboratory parameters (gamma-glutamyltransferase) as change from baseline
Time frame: week 24
Laboratory parameters (aspartate aminotransferase in U/L) as change from baseline
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Time frame: week 24
Laboratory parameters (alanine aminotransferase in U/L) as change from baseline
Time frame: week 24
Laboratory parameters (lactate dehydrogenase in U/L) as change from baseline
Time frame: week 24
Laboratory parameters (glutamate dehydrogenase in U/L) as change from baseline
Time frame: week 24
Laboratory parameters (creatinine in µmol/L) as change from baseline
Time frame: week 24
Laboratory parameters (c-reactive protein in mg/L) as change from baseline
Time frame: week 24
Laboratory parameters (cholinesterase in kU/L) as change from baseline
Time frame: week 24
To analyze course of liver function (Model for endstage liver disease score as changes from baseline)
Model for End-Stage Liver Disease (MELD) score 0-40 points with higher values indicating increasing impairment of liver function
Time frame: week 24
Occurrence of unplanned Intensive care unit (ICU) admissions (necessity and days free of: intensive care unit care, invasive ventilation, renal replacement therapy, vasopressors within 6 months)
Time frame: week 24
To analyze the need for anti-infective therapy (antibiotic treatment) in the different study arms
Necessity of treatment with anti-infective medication (= treament with antibiotic oral or intravenously for acute cholangitis) (yes/no)
Time frame: week 24
Occurrence of unplanned hospital admissions (necessity and days free of hospital care within 6 months)
Time frame: week 24