Unique ID issued by UMIN | UMIN000019814 |
---|---|
Receipt number | R000022893 |
Scientific Title | Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial) |
Date of disclosure of the study information | 2015/12/01 |
Last modified on | 2019/06/05 21:51:08 |
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)
Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)
Japan |
Acute cholangitis
Hepato-biliary-pancreatic medicine |
Others
NO
To compare the recurrence rate after successful biliary drainage for acute gallstone cholangitis between fever-based antibiotic therapy group and guideline-based antibiotic therapy group, and to verify that the recurrence rates of cholangitis are similar in both groups.
Safety
Confirmatory
The recurrence rate of cholangitis within 30 days after withdrawal of antibiotic therapy.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Other |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
250
1st name | Yousuke |
Middle name | |
Last name | Nakai |
Faculty of Medicine, The University of Tokyo
Department of Gastroenterology
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
ynakai-tky@umin.ac.jp
1st name | Ryunosuke |
Middle name | |
Last name | Hakuta |
Faculty of Medicine, The University of Tokyo
Department of Gastroenterology
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
hakuta-tky@umin.ac.jp
The University of Tokyo Hospital
Thermo Fisher Scientific K.K.
Profit organization
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
IRB of the University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-5800-8775
crctky-office@umin.ac.jp
NO
東京大学 消化器内科 The University of Tokyo
東京高輪病院 消化器内科 Tokyo Takanawa Hospital
日本赤十字社医療センター 消化器内科 Japan Red Cross medical center
JR東京総合病院 消化器内科 JR Tokyo General Hospital
関東中央病院 消化器内科 Kanto Central Hospital
東京警察病院 消化器内科 Tokyo Metropolitan Police Hospital
三井記念病院 消化器内科 Mitsui Memorial Hospital
東芝病院 消化器内科 Toshiba General Hospital
帝京大学医学部附属溝口病院 消化器内科 Teikyo University Mizonokuchi Hospital
岐阜大学 第一内科 Gifu University Hospital
岐阜市民病院 消化器内科 Gifu Municipal Hospital
埼玉医科大学総合医療センター 消化器・肝臓内科 Saitama Medical Center
聖マリアンナ医科大学 消化器・肝臓内科 St. Marianna University Hospital
2015 | Year | 12 | Month | 01 | Day |
Unpublished
54
Completed
2015 | Year | 09 | Month | 01 | Day |
2015 | Year | 07 | Month | 23 | Day |
2016 | Year | 04 | Month | 01 | Day |
2018 | Year | 11 | Month | 14 | Day |
2015 | Year | 11 | Month | 16 | Day |
2019 | Year | 06 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022893
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |