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

NCT05396755 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-10-11

No results posted yet for this study

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

Interventions

PROCEDURE

Endoscopic retrograde cholangiography (ERC)

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

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Hans H. Wedemeyer, Prof. · Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2023-09-14
Completion
2023-09-14

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05396755 on ClinicalTrials.gov