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

NCT05396755 | Terminated DMC

• 1 other identifier: BISCIT
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Sclerosing Cholangitis

Keywords

biliary intervention; endoscopic therapy; endoscopic retrograde cholangiography

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (14)

• 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

• Laboratory parameters (gamma-glutamyltransferase) as change from baseline

  week 24

• Laboratory parameters (aspartate aminotransferase in U/L) as change from baseline

  week 24

• Laboratory parameters (alanine aminotransferase in U/L) as change from baseline

  week 24

Other Outcomes (5)

• Changes in specific signatures in biliary microbiome

  day1, week 8, week 16, week 24

• To analyze the extent of biliary tract damage at magnetic resonance cholangiopancreatography (MRCP) in the different study arms.

  week 24

• Occurrence of infections: cholangitis, cholecystitis

  up to week 48

Study Arms (2)

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.

Procedure: Endoscopic retrograde cholangiography (ERC)

control

NO INTERVENTION

The control group receives non-interventional standard of care.

Interventions

Endoscopic retrograde cholangiography (ERC) PROCEDURE

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

interventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is too unstable to undergo ERC
• Pregnancy or lactation period

Sponsors & Collaborators

• Hannover Medical School: lead
• German Research Foundation: collaborator

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 37004078 DERIVED

Study Officials

• Hans H. Wedemeyer, Prof.

  Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, open-label, controlled, parallel group, multicenter

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 31, 2022
• Study Start: November 14, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)