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Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)

Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial) - Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019814
Enrollment
250
Registered
2015-12-01
Start date
2016-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute cholangitis

Interventions

Fever-based group: When the body temperature under 37 degrees Celcius is maintained for 24 hrs, administration of antibiotics is stopped. Guideline-based Group: Antibiotics are administered for 4 to 7

Sponsors

The University of Tokyo Hospital
Lead Sponsor
1.Tokyo Takanawa Hospital 2.Japan Red Cross medical center 3.JR Tokyo General Hospital 4.Kanto Central Hospital 5.Tokyo Metropolitan Police Hospital 6.Mitsui Memorial Hospital 7.Toshiba General Hospital 8.Teikyo University Mizonokuchi Hospital 9.Gifu University Hospital 10.Gifu Municipal Hospital 11.Saitama Medical Center 12.St. Marianna University Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria for acute cholangitis according to Tokyo Guidelines 2013 (TG13). 2. Patients with "moderate" or "severe" acute cholangitis, which is defined by TG13. 3. Patients who received endoscopic biliary drainage within 12 hrs after diagnosis. 4. Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute pancreatitis 2. Patients with other active concomitant infections (liver abscess, pneumonia, infective endocarditis, etc.) 3. Patients with undrained bile ducts due to multiple biliary strictures. 4. Patients who have undergone biliary stenting or percutaneous biliary drainage. 5. Patients with previous choledochojejunostomy. 6. Patients who have participated in this study. 7. Patients receiving steroid or immunosuppressive agent. 8. Patients who have antipyretic analgesics or NSAIDs within 24 hrs before the diagnosis of cholangitis. 9. Patients receiving chemotherapy. 10. Patients who have received antibiotics within 2 weeks before the diagnosis of cholangitis. 11. Patients considered ineligible for this study.

Design outcomes

Primary

MeasureTime frame
The recurrence rate of cholangitis within 30 days after withdrawal of antibiotic therapy.—

Countries

Japan

Contacts

Public ContactRyunosuke Hakuta

Faculty of Medicine, The University of Tokyo Department of Gastroenterology

hakuta-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026