Stahl, Klaus and Klein, Friederike and Voigtlaender, Torsten and Grosshennig, Anika and Book, Thorsten and Mueller, Tobias M. and Wree, Alexander and Kuellmer, Armin and Weigt, Jochen I. and Dechene, Alexander and Wedi, Edris and Kandulski, Arne and Lange, Christian and Holzwart, Dennis and von Witzendorff, Dorothee and Ringe, Kristina and Wedemeyer, Heiner M. and Heidrich, Benjamin (2023) BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis-a study protocol for a multicenter, randomized, controlled parallel group trial. TRIALS, 24 (1): 247. ISSN , 1745-6215
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SEPTIC SHOCK; SEPSIS; SCORE; BILE; Secondary sclerosing cholangitis; Critical ill patients; Biliary interventions; Randomized-controlled trial; Cholangiosepsis; Endoscopic retrograde cholangiography |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Apr 2024 06:27 |
| Last Modified: | 09 Apr 2024 06:27 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60681 |
Actions (login required)
 |
View Item |
