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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001705
Receipt No. R000002053
Scientific Title Short-term antibiotic therapy for acute cholangitis after successful endoscopic biliary drainage
Date of disclosure of the study information 2009/02/13
Last modified on 2009/12/21

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Basic information
Public title Short-term antibiotic therapy for acute cholangitis after successful endoscopic biliary drainage
Acronym Short-term antibiotic therapy for acute cholangitis after successful endoscopic biliary drainage
Scientific Title Short-term antibiotic therapy for acute cholangitis after successful endoscopic biliary drainage
Scientific Title:Acronym Short-term antibiotic therapy for acute cholangitis after successful endoscopic biliary drainage
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of short-term antibiotic therapy for acute cholangitis after successful biliary drainage
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes recurrence rate of cholangitis 3 days after withdrawal of antibiotic therapy
Key secondary outcomes 1)Period until normalization of inflammation markers (WBC and CRP)
2)Incidence of complications (liver abscess and sepsis, etc.) related to
cholangitis
3)Readministration rate of antibiotics
4)medical costs

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous antibiotics therapy for patients diagnosed with acute cholangitis is started immediately.
When < 37 degrees body temperature is maintained for 24 hrs, administration of antibiotics is stopped.
Interventions/Control_2
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 with "moderate" or "severe" acute cholangitis, which is defined by "Tokyo Guidelines for the management of acute cholangitis and cholecystitis" and received biliary drainage within 24 hrs after diagnosis
2)Patients of age >= 20 years
3)Written informed consent is reqired from all patients.
Key exclusion criteria 1)Patients with the most severe cholangitis requiring catecholamine administration, mechanical ventilation management, or hemodialysis
2)Patients with acute pancreatitis
3)Patients with other active concomitant infections
4)Patients without adequate drainage due to remaining biliary strictures
5)Patients who have undergone biliary stenting or percutaneous biliary drainage
6)Patients with sclerosing cholangitis
7)Patients with previous choledochojejunostomy
8)Patients with previous heart valve replacement
9)Patients with severe cardiovascular disease
10)Patients receiving maintenance hemodialysis
11)Patients with previous history of antibiotic hypersensitivity
12)Patients receiving chemotherapy
13)Patients receiving steroid or immunosuppressive agent
14)Patients who have received antibiotics within 4 weeks before the pre-observation period
15)Inappropriate patients for entry on this study by the judgement of the investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Tsujino
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Kogure
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email

Sponsor
Institute Faculty of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 13 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
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
2007 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 13 Day
Last modified on
2009 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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