Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-09-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Secondary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, open-label, controlled, parallel group, multicenter

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interventional

The intervention group undergoes scheduled invasive evaluation of the biliary tract with endoscopic retrograde cholangiography (ERC) with biliary interventions (i.e. therapeutic ERC) every 8 weeks for 6 months.

Group Type EXPERIMENTAL

Endoscopic retrograde cholangiography (ERC)

Intervention Type PROCEDURE

invasive evaluation of the biliary tract with ERC and endoscopic interventions every 8 weeks until 6 months (24 weeks)

control

The control group receives non-interventional standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endoscopic retrograde cholangiography (ERC)

invasive evaluation of the biliary tract with ERC and endoscopic interventions every 8 weeks until 6 months (24 weeks)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Men, women\*, inter/divers, age ≥18 and ≤ 80 years (conscious or unconscious patients may be included)
2. Signed written informed consent obtained by patient or legal representative in case of unconscious patient
3. Willingness to comply with treatment and follow-up procedures
4. Suspected SSC-CIP = episode of critical illness and intensive care unit treatment \> 3 days within last 12 months
5. 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)
6. Elevation of bilirubin ≥ 2.5 upper limit of normal (ULN) at Screening
7. Elevation of alkaline phosphatase (AP) or gamma-glutamyl-transferase (GGT) \> 2.5 ULN or elevation of both at Screening
8. \*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.