Secondary Sclerosing CholangitisBISCITNCT05396755
Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)
A study testing Endoscopic retrograde cholangiography (ERC) in people with Secondary Sclerosing Cholangitis, run by Hannover Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Secondary Sclerosing Cholangitis
- What is being tested?
- Endoscopic retrograde cholangiography (ERC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 14 Nov 2022to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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.
Who cannot join
- Patient is too unstable to undergo ERC
- Inclusion in any other intervention trial within the last 30 days
- Pregnancy or lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis - a Multicenter, Randomized Controlled, Parallel Group Trial
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.
- Conditions
- Secondary Sclerosing Cholangitis
- Being tested
- Endoscopic retrograde cholangiography (ERC)
- Keywords
- biliary intervention, endoscopic therapy, endoscopic retrograde cholangiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiography (ERC)Procedure or surgery
invasive evaluation of the biliary tract with ERC and endoscopic interventions every 8 weeks until 6 months (24 weeks)
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | 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. Receives: Procedure: Endoscopic retrograde cholangiography (ERC) |
| control | No intervention | The control group receives non-interventional standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to week 48
Secondary outcomes (14)
Laboratory parameters (bilirubin in µmol/L) as change from baseline
Measured: week 24
Laboratory parameters (alkaline phosphatase in U/L) as change from baseline
Measured: week 24
Laboratory parameters (gamma-glutamyltransferase) as change from baseline
Measured: week 24
Laboratory parameters (aspartate aminotransferase in U/L) as change from baseline
Measured: week 24
Laboratory parameters (alanine aminotransferase in U/L) as change from baseline
Measured: week 24
Laboratory parameters (lactate dehydrogenase in U/L) as change from baseline
Measured: week 24
Laboratory parameters (glutamate dehydrogenase in U/L) as change from baseline
Measured: week 24
Laboratory parameters (creatinine in µmol/L) as change from baseline
Measured: week 24
Laboratory parameters (c-reactive protein in mg/L) as change from baseline
Measured: week 24
Laboratory parameters (cholinesterase in kU/L) as change from baseline
Measured: 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
Measured: 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)
Measured: 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)
Measured: week 24
Occurrence of unplanned hospital admissions (necessity and days free of hospital care within 6 months)
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start14 Nov 2022
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Why it stopped: Study was stopped due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, open-label, controlled, parallel group, multicenter
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Hans H. Wedemeyer, Prof., Principal investigator, Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396755
- Sponsor's protocol ID
- BISCIT
- Acronym
- BISCIT
- Status last verified
- Oct 2023
- First submitted
- 3 May 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stahl K, Klein F, Voigtlander T, Grosshennig A, Book T, Muller T, Wree A, Kuellmer A, Weigt J, Dechene A, Wedi E, Kandulski A, Lange CM, Holzwart D, von Witzendorff D, Ringe KI, Wedemeyer H, Heidrich B; BISCIT Study group. BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis-a study protocol for a multicenter, randomized, controlled parallel group trial. Trials. 2023 Mar 31;24(1):247. doi: 10.1186/s13063-023-07260-w.
PubMed 37004078
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis - a Multicenter, Randomized Controlled, Parallel Group Trial
- ClinicalTrials.gov ID
- NCT05396755
- Acronym / sponsor ID
- BISCIT / BISCIT
- Conditions
- Secondary Sclerosing Cholangitis
- Keywords
- biliary intervention, endoscopic therapy, endoscopic retrograde cholangiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to insufficient recruitment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, open-label, controlled, parallel group, multicenter
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Procedure: Endoscopic retrograde cholangiography (ERC)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. |
| control | No intervention | –The control group receives non-interventional standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (3 listed)
- Patient is too unstable to undergo ERC
- Inclusion in any other intervention trial within the last 30 days
- Pregnancy or lactation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic retrograde cholangiography (ERC)invasive evaluation of the biliary tract with ERC and endoscopic interventions every 8 weeks until 6 months (24 weeks) | Procedure or surgery | interventional |
Primary outcome
occurrence of death
Time frame: 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
Time frame: 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 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
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.
14 secondary outcomes
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
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)
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
Time frame: week 24
Occurrence of unplanned hospital admissions (necessity and days free of hospital care within 6 months)
Time frame: week 24
Results and safety
The study was stopped early (reason given: Study was stopped due to insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 37004078Stahl K, Klein F, Voigtlander T, Grosshennig A, Book T, Muller T, Wree A, Kuellmer A, Weigt J, Dechene A, Wedi E, Kandulski A, Lange CM, Holzwart D, von Witzendorff D, Ringe KI, Wedemeyer H, Heidrich B; BISCIT Study group. BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis-a study protocol for a multicenter, randomized, controlled parallel group trial. Trials. 2023 Mar 31;24(1):247. doi: 10.1186/s13063-023-07260-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans H. Wedemeyer, Prof. principal investigator
Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic retrograde cholangiography (ERC) in people with Secondary Sclerosing Cholangitis, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to insufficient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of death (time frame: up to week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.