Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT) (NCT05396755) | Clinical Trial Compass
TerminatedNot Applicable
Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)
Stopped: Study was stopped due to insufficient recruitment.
Germany1 participantsStarted 2022-11-14
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Men, women\*, inter/divers, age ≥18 and ≤ 80 years (conscious or unconscious patients may be included)
✓. Signed written informed consent obtained by patient or legal representative in case of unconscious patient
✓. Willingness to comply with treatment and follow-up procedures
✓. Suspected SSC-CIP = episode of critical illness and intensive care unit treatment \> 3 days within last 12 months
✓. SSC-CIP is confirmed by ERC, (if the first ERC is performed at baseline, the patient may be considered as screening failure if the diagnosis is not confirmed)
✓. Elevation of bilirubin ≥ 2.5 upper limit of normal (ULN) at Screening
✓. Elevation of alkaline phosphatase (AP) or gamma-glutamyl-transferase (GGT) \> 2.5 ULN or elevation of both at Screening
✓. \*Women without childbearing potential defined as follows:
Exclusion criteria
✕
What they're measuring
1
occurrence of death
Timeframe: up to week 48
2
necessity of liver transplantation
Timeframe: up to week 48
3
occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.