UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001705 |
|---|---|
| Receipt number | 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 16:47:35 |
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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
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
Sponsor or person
Institute
Faculty of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002053
