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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002375
Receipt No. R000002918
Scientific Title Usefulness of oral kanamycin for retrograde infection after biliary stent placement
Date of disclosure of the study information 2009/09/01
Last modified on 2016/02/24

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Basic information
Public title Usefulness of oral kanamycin for retrograde infection after biliary stent placement
Acronym Usefulness of oral kanamycin for
stent occlusion
Scientific Title Usefulness of oral kanamycin for retrograde infection after biliary stent placement
Scientific Title:Acronym Usefulness of oral kanamycin for
stent occlusion
Region
Japan

Condition
Condition Obstructive jaundice
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the effects of oral kanamycin on prevention of biliary stent occlusion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes biliary stent occlusion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 plastic stent - oral kanamycin in group
Interventions/Control_2 plastic stent - group without oral kanamycin
Interventions/Control_3 metal stent - oral kanamycin in group
Interventions/Control_4 metal stent - group without oral kanamycin
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
100 years-old >=
Gender Male and Female
Key inclusion criteria For obstructive jaundice, patients requiring long-term biliary stent placement.
Key exclusion criteria 1.patients already have oral kanamycin prior to stenting
2.history of upper gastrointestinal
3.patients with hearing loss
4.severe renal dysfunction (serum creatinine> 2.0mg/dl) the merger of the patient
5.patients unable to take oral medication
6.pregnant women, nursing mothers, and pregnant women suspected
7.other patients deemed inappropriate for this exam by the doctor
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shingo kato
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa,236-0004, Japan
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name shingo kato
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Zip code
Address
TEL 045-787-2800
Homepage URL
Email

Sponsor
Institute Gastroenterology Division, Yokohama City University Hospital
Institute
Department

Funding Source
Organization Gastroenterology Division, Yokohama City University Hospital
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 09 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
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 Terminated
Date of protocol fixation
2009 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 08 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 08 Month 24 Day
Last modified on
2016 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002918

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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