Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Mar 31;24(1):247.
doi: 10.1186/s13063-023-07260-w.

BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis-a study protocol for a multicenter, randomized, controlled parallel group trial

Klaus Stahl  1 , Friederike Klein  2 , Torsten Voigtländer  3 , Anika Großhennig  4 , Thorsten Book  3 , Tobias Müller  5 , Alexander Wree  5 , Armin Kuellmer  6 , Jochen Weigt  7 , Alexander Dechene  8 , Edris Wedi  9 , Arne Kandulski  10 , Christian M Lange  11 , Dennis Holzwart  4 , Dorothee von Witzendorff  2 , Kristina I Ringe  12   13 , Heiner Wedemeyer  2 , Benjamin Heidrich  2 ; BISCIT Study group
Collaborators, Affiliations

BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis-a study protocol for a multicenter, randomized, controlled parallel group trial

Klaus Stahl et al. Trials. .

Abstract

Background: Progress of cholangitis to cholangiosepsis is a frequent observation in patients with secondary sclerosing cholangitis in critically ill patients (SSC-CIP). Adequate biliary drainage may reduce episodes of cholangiosepsis and therefore stabilize liver function and improve survival. The primary objective of the BISCIT study is to demonstrate that scheduled biliary interventions will reduce incidence of cholangiosepsis, liver transplantation, or death in patients with SSC-CIP.

Methods: A total of 104 patients will be randomized at ten study sites. Patients with SSC-CIP, confirmed by endoscopic retrograde cholangiography (ERC), will be randomized 1:1 either in the intervention group which will be treated with scheduled biliary interventions (i.e., therapeutic ERC) every 8 weeks for 6 months or in the control group which will receive standard of care. The randomization will be stratified by center. The composite primary efficacy endpoint is defined as (1) occurrence of death, (2) necessity of liver transplantation, or (3) occurrence of cholangiosepsis within 6 months following randomization.

Discussion: Prospective evaluation of endoscopic treatment procedures is urgently needed to establish an evidence-based therapeutic treatment algorithm in SSC-CIP. A positive trial result could change the current standard of care for patients with SSC-CIP. The results of this study will be disseminated through presentations at international congresses, workshops, and peer-reviewed publications.

Trial registration: The trial was registered at ClinicalTrials.gov (NCT05396755, date of registration: May 31, 2022, last update: May 31, 2022).

Keywords: Biliary interventions; Cholangiosepsis; Critical ill patients; Endoscopic retrograde cholangiography; Randomized-controlled trial; Secondary sclerosing cholangitis.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial structure
See this image and copyright information in PMC

References

    1. Abdalian R, Heathcote EJ. Sclerosing cholangitis: a focus on secondary causes. Hepatology. 2006;44(5):1063–1074. doi: 10.1002/hep.21405. - DOI - PubMed
    1. Engler S, Elsing C, Flechtenmacher C, Theilmann L, Stremmel W, Stiehl A. Progressive sclerosing cholangitis after septic shock: a new variant of vanishing bile duct disorders. Gut. 2003;52(5):688–693. doi: 10.1136/gut.52.5.688. - DOI - PMC - PubMed
    1. Jaeger C, Mayer G, Henrich R, Gossner L, Rabenstein T, May A, et al. Secondary sclerosing cholangitis after long-term treatment in an intensive care unit: clinical presentation, endoscopic findings, treatment, and follow-up. Endoscopy. 2006;38(7):730–734. doi: 10.1055/s-2006-925241. - DOI - PubMed
    1. Gelbmann CM, Rümmele P, Wimmer M, Hofstädter F, Göhlmann B, Endlicher E, et al. Ischemic-like cholangiopathy with secondary sclerosing cholangitis in critically ill patients. Am J Gastroenterol. 2007;102(6):1221–1229. doi: 10.1111/j.1572-0241.2007.01118.x. - DOI - PubMed
    1. Kulaksiz H, Heuberger D, Engler S, Stiehl A. Poor outcome in progressive sclerosing cholangitis after septic shock. Endoscopy. 2008;40(3):214–218. doi: 10.1055/s-2007-967024. - DOI - PubMed

Publication types

MeSH terms

Associated data