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

Secondary Sclerosing Cholangitis Clinical Trial

— BISCIT  

Official title:

Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis - a Multicenter, Randomized Controlled, Parallel Group Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05396755
• Other study ID #: BISCIT
• Status: Terminated
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: September 14, 2023

Study information

• Verified date: October 2023
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 non-interventional standard of care to demonstrate that programmed endoscopic therapy compared to a conservative strategy reduces the occurrence of treatment failures.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients have to fulfill all of the following inclusion criteria to be eligible for participation in this study:

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.

Exclusion Criteria:

1. Patient is too unstable to undergo ERC

2. Inclusion in any other intervention trial within the last 30 days

3. Pregnancy or lactation period

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Neoplasm Metastasis
• Secondary Sclerosing Cholangitis

Intervention

Procedure:
• Endoscopic retrograde cholangiography (ERC)
invasive evaluation of the biliary tract with ERC and endoscopic interventions every 8 weeks until 6 months (24 weeks)

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in specific signatures in biliary microbiome		day1, week 8, week 16, week 24
Other	To analyze the extent of biliary tract damage at magnetic resonance cholangiopancreatography (MRCP) in the different study arms.	Extent of bile duct damage at 6-months MRCP compared to baseline as determined by central radiology reading	week 24
Other	Occurrence of infections: cholangitis, cholecystitis		up to week 48
Other	Occurrence of ERC-related complications: bleeding, perforation, pancreatitis, cholangitis,		day1, week 8, week 16, week 24
Other	occurrence of serious adverse events	population	day1, week 8, week 16, week 24, week 32, week 40, week 48
Primary	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.	up to week 48
Primary	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.	up to week 48
Primary	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.	up to week 48
Secondary	Laboratory parameters (bilirubin in µmol/L) as change from baseline		week 24
Secondary	Laboratory parameters (alkaline phosphatase in U/L) as change from baseline		week 24
Secondary	Laboratory parameters (gamma-glutamyltransferase) as change from baseline		week 24
Secondary	Laboratory parameters (aspartate aminotransferase in U/L) as change from baseline		week 24
Secondary	Laboratory parameters (alanine aminotransferase in U/L) as change from baseline		week 24
Secondary	Laboratory parameters (lactate dehydrogenase in U/L) as change from baseline		week 24
Secondary	Laboratory parameters (glutamate dehydrogenase in U/L) as change from baseline		week 24
Secondary	Laboratory parameters (creatinine in µmol/L) as change from baseline		week 24
Secondary	Laboratory parameters (c-reactive protein in mg/L) as change from baseline		week 24
Secondary	Laboratory parameters (cholinesterase in kU/L) as change from baseline		week 24
Secondary	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	week 24
Secondary	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
Secondary	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)	week 24
Secondary	Occurrence of unplanned hospital admissions (necessity and days free of hospital care within 6 months)		week 24