UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019814
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)
Acronym Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)
Scientific Title Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)
Scientific Title:Acronym Fever-based versus guideline-based antibiotic therapy for acute cholangitis following successful endoscopic biliary drainage: a multicenter randomized trial (FANTASTIC trial)
Region
Japan

Condition
Condition Acute cholangitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The recurrence rate of cholangitis within 30 days after withdrawal of antibiotic therapy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Fever-based group: When the body temperature under 37 degrees Celcius is maintained for 24 hrs, administration of antibiotics is stopped.
Interventions/Control_2 Guideline-based Group: Antibiotics are administered for 4 to 7 days according to Tokyo Guidelines 2013.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Yousuke
Middle name
Last name Nakai
Organization Faculty of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email ynakai-tky@umin.ac.jp

Public contact
Name of contact person
1st name Ryunosuke
Middle name
Last name Hakuta
Organization Faculty of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email hakuta-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Thermo Fisher Scientific K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-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
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of the University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5800-8775
Email crctky-office@umin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 54
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
2015 Year 07 Month 23 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 11 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 16 Day
Last modified on
2019 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.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


Contact us.