UMIN ID: UMIN000019814
Registered date:01/12/2015
Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute cholangitis |
| Date of first enrollment | 2016/04/01 |
| Target sample size | 250 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 days according to Tokyo Guidelines 2013. |
Outcome(s)
| Primary Outcome | The recurrence rate of cholangitis within 30 days after withdrawal of antibiotic therapy. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | The University of Tokyo Hospital |
|---|---|
| Secondary 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 |
| Source(s) of Monetary Support | Thermo Fisher Scientific K.K. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ryunosuke Hakuta |
| Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan 113-8655 |
| Telephone | 03-3815-5411 |
| hakuta-tky@umin.ac.jp | |
| Affiliation | Faculty of Medicine, The University of Tokyo Department of Gastroenterology |
| scientific contact | |
| Name | Yousuke Nakai |
| Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan |
| Telephone | 03-3815-5411 |
| ynakai-tky@umin.ac.jp | |
| Affiliation | Faculty of Medicine, The University of Tokyo Department of Gastroenterology |