JPRN-UMIN000054071
Not yet recruiting
Phase 3
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) - BOLT-P3
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shonan Kamakura General Hospital
- Enrollment
- 210
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
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