BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis—a study protocol for a multicenter, randomized, controlled parallel group trial
Klaus Stahl,
Friederike Klein,
Torsten Voigtländer,
Anika Großhennig,
Thorsten Book,
Tobias Müller,
Alexander Wree,
Armin Kuellmer,
Jochen Weigt,
Alexander Dechene,
Edris Wedi,
Arne Kandulski,
Christian M. Lange,
Dennis Holzwart,
Dorothee von Witzendorff,
Kristina I. Ringe,
Heiner Wedemeyer,
Benjamin Heidrich,
for the BISCIT Study group
Affiliations
Klaus Stahl
Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
Friederike Klein
Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
Torsten Voigtländer
Department of Gastroenterology, Clementinenkrankenhaus Hannover
Anika Großhennig
Department of Biostatistics, Hannover Medical School
Thorsten Book
Department of Gastroenterology, Clementinenkrankenhaus Hannover
Tobias Müller
Department of Hepatology and Gastroenterology, Charite University Medicine Berlin, Campus Charite Mitte/Campus Virchow Clinic
Alexander Wree
Department of Hepatology and Gastroenterology, Charite University Medicine Berlin, Campus Charite Mitte/Campus Virchow Clinic
Armin Kuellmer
Clinic for Gastroenterology, Hepatology, Endocrinology and Infectious Diseases, University Hospital Freiburg
Jochen Weigt
Clinic for Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg
Alexander Dechene
Department of Gastroenterology and Endocrinology, Hospital Nurnberg
Edris Wedi
Department of Gastroenterology, Gastro-Oncology and Interventional Endoscopy, Sana Hospital Offenbach
Arne Kandulski
Department of Gastroenterology, Endocrinology, Infectious Diseases and Rheumatology, University Hospital Regensburg
Christian M. Lange
Department of Gastroenterology and Hepatology, University Hospital Munich (LMU)
Dennis Holzwart
Department of Biostatistics, Hannover Medical School
Dorothee von Witzendorff
Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
Kristina I. Ringe
Department of Diagnostic and Interventional Radiology, Hannover Medical School
Heiner Wedemeyer
Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
Benjamin Heidrich
Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
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).
