UMIN-CTR Clinical Trial

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

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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 or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



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

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