BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis-a study protocol for a...

Area of Science:

• Gastroenterology
• Hepatology
• Critical Care Medicine

Background:

• Secondary sclerosing cholangitis in critically ill patients (SSC-CIP) frequently progresses to cholangiosepsis.
• Adequate biliary drainage is crucial for stabilizing liver function and improving survival in SSC-CIP patients.

Purpose of the Study:

• To evaluate if scheduled biliary interventions reduce the incidence of cholangiosepsis, liver transplantation, or death in patients with SSC-CIP.
• To establish an evidence-based therapeutic algorithm for SSC-CIP.

Main Methods:

• A randomized controlled trial involving 104 patients with SSC-CIP confirmed by endoscopic retrograde cholangiography (ERC).
• Patients were randomized 1:1 to receive either scheduled therapeutic ERC every 8 weeks for 6 months or standard of care.
• The primary endpoint was a composite of death, liver transplantation, or cholangiosepsis within 6 months.

Main Results:

• The study is ongoing and results are pending.
• Data will be disseminated through congress presentations and peer-reviewed publications.

Conclusions:

• Prospective evaluation of endoscopic treatment is essential for developing evidence-based guidelines in SSC-CIP.
• Positive trial results could significantly alter the current standard of care for SSC-CIP patients.