UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000022893