Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3)

UMIN ID: UMIN000054071

Registered date:09/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Acute cholangitis
• Date of first enrollment: 2024/04/15
• Target sample size: 210
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

This study aims to verify that the efficacy of antibiotic treatment for acute cholangitis following biliary drainage in the trial treatment group, lasting 24-72 hours, is not inferior to that in the standard treatment group, which lasts 96-168 hours. For the trial treatment group (method and type of antibiotic administration): Antibiotics are principally administered intravenously. The administration period is 24-72 hours after sufficient biliary drainage has been achieved. To clarify the difference from the standard treatment group, the antibiotic administration duration is specifically set to 24-72 hours. Similar to the standard treatment group, following the recommendations of TG18, a choice is made from aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, sulfonamides, and penicillins. The specific choice of medication is not strictly defined but may be altered based on allergies, local protocols, and previous culture results.
For the standard treatment group (method and type of antibiotic administration): Antibiotics are principally administered intravenously. The administration period is 96-168 hours after sufficient biliary drainage has been achieved. To clearly differentiate from the trial treatment group, the antibiotic administration duration in this study is specifically set to 96-168 hours. Following the recommendations of Tokyo Guideline 2018 (TG18), a choice is made from aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, sulfonamides, and penicillins. The specific choice of medication is not strictly defined but may be altered based on allergies, local protocols, and previous culture results.

Outcome(s)

• Primary Outcome: The primary outcome is defined as the rate of cases that achieve clinical cure within 14 days and survive without recurrence.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Circulatory insufficiency with catecholamines at ERCP time. ICU need. Hypothermia below 35 degrees Celsius. Recurrent cholangitis within 3 months. Biliary stricture >= Bismuth 2 or unclear biliary block. Post-surgery anatomical changes like biliary-jejunal anastomosis. Pancreatitis per International Pancreatic Society/American Pancreatic Association: Upper abdominal pain, serum amylase/lipase >3x ULN, acute pancreatitis imaging. Cholecystitis by TG18: A (Murphy's sign/right upper quadrant issues) + B (fever >37.1 degrees Celsius, CRP >3.0 mg/dL, WBC >10,000 uL) + C (acute cholecystitis imaging). Hepatic abscess. Other infections. Pre-registration continuous antibiotics. Pre-registration ERCP complications (perforation, pancreatitis, bleeding, cholecystitis, sedation-related issues). Immunosuppression: A (>10 mg prednisolone), B (HIV), C (neutrophils <=1500 uL), D (recent hematopoietic stem cell transplantation). Pregnancy. Other exclusions by physician.

Related Information

• Primary Sponsor: Shonan Kamakura General Hospital
• Source(s) of Monetary Support: Shonan Kamakura General Hospital