Status:
TERMINATED
Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
German Research Foundation
Conditions:
Secondary Sclerosing Cholangitis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 interventi...
Eligibility Criteria
Inclusion
- Patients have to fulfill all of the following inclusion criteria to be eligible for participation in this study:
- 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:
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- hysterectomy or uterine agenesis or
- ≥ 50 years and in postmenopausal state \> 1 year or
- \< 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:
- who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
- who have sexual relationships with female partners only and/or with sterile male partners or
- 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.
Exclusion
- Patient is too unstable to undergo ERC
- Inclusion in any other intervention trial within the last 30 days
- Pregnancy or lactation period
Key Trial Info
Start Date :
November 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05396755
Start Date
November 14 2022
End Date
September 14 2023
Last Update
October 11 2023
Active Locations (1)
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1
Hannover Medical School
Hanover, Lower Saxony, Germany, 30625