Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)
- Conditions
- Secondary Sclerosing Cholangitis
- Registration Number
- NCT05396755
- Lead Sponsor
- Hannover Medical School
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Patients have to fulfill all of the following inclusion criteria to be eligible for participation in this study:
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Men, women*, inter/divers, age ≥18 and ≤ 80 years (conscious or unconscious patients may be included)
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Signed written informed consent obtained by patient or legal representative in case of unconscious patient
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Willingness to comply with treatment and follow-up procedures
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Suspected SSC-CIP = episode of critical illness and intensive care unit treatment > 3 days within last 12 months
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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)
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Elevation of bilirubin ≥ 2.5 upper limit of normal (ULN) at Screening
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Elevation of alkaline phosphatase (AP) or gamma-glutamyl-transferase (GGT) > 2.5 ULN or elevation of both at Screening
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*Women without childbearing potential defined as follows:
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at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
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hysterectomy or uterine agenesis or
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≥ 50 years and in postmenopausal state > 1 year or
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< 50 years and in postmenopausal state > 1 year with serum Follicle Stimulating Hormone (FSH) > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening or
*Women of childbearing potential:
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who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
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who have sexual relationships with female partners only and/or with sterile male partners or
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who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception (failure rate of < 1% per year) from the time of screening until end of the clinical trial.
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- Patient is too unstable to undergo ERC
- Inclusion in any other intervention trial within the last 30 days
- Pregnancy or lactation period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first. up to week 48 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.necessity of liver transplantation up to week 48 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.occurrence of death up to week 48 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.
- Secondary Outcome Measures
Name Time Method Laboratory parameters (creatinine in µmol/L) as change from baseline week 24 Laboratory parameters (bilirubin in µmol/L) as change from baseline week 24 Laboratory parameters (alkaline phosphatase in U/L) as change from baseline week 24 To analyze course of liver function (Model for endstage liver disease score as changes from baseline) week 24 Model for End-Stage Liver Disease (MELD) score 0-40 points with higher values indicating increasing impairment of liver function
Laboratory parameters (alanine aminotransferase in U/L) as change from baseline week 24 Laboratory parameters (glutamate dehydrogenase in U/L) as change from baseline week 24 Laboratory parameters (c-reactive protein in mg/L) as change from baseline week 24 Laboratory parameters (gamma-glutamyltransferase) as change from baseline week 24 Laboratory parameters (lactate dehydrogenase in U/L) as change from baseline 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) week 24 Laboratory parameters (cholinesterase in kU/L) as change from baseline week 24 To analyze the need for anti-infective therapy (antibiotic treatment) in the different study arms week 24 Necessity of treatment with anti-infective medication (= treament with antibiotic oral or intravenously for acute cholangitis) (yes/no)
Occurrence of unplanned hospital admissions (necessity and days free of hospital care within 6 months) week 24 Laboratory parameters (aspartate aminotransferase in U/L) as change from baseline week 24
Trial Locations
- Locations (1)
Hannover Medical School
🇩🇪Hannover, Lower Saxony, Germany
Hannover Medical School🇩🇪Hannover, Lower Saxony, Germany