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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026538
Receipt No. R000030476
Scientific Title Multicenter prospective study of feasibility and safety of radio frequency ablation for malignant biliary stricture under ERCP guidance
Date of disclosure of the study information 2017/03/14
Last modified on 2017/03/14

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Basic information
Public title Multicenter prospective study of feasibility and safety of radio frequency ablation for malignant biliary stricture under ERCP guidance
Acronym Multicenter prospective study of feasibility and safety of radio frequency ablation under ERCP guidance
Scientific Title Multicenter prospective study of feasibility and safety of radio frequency ablation for malignant biliary stricture under ERCP guidance
Scientific Title:Acronym Multicenter prospective study of feasibility and safety of radio frequency ablation under ERCP guidance
Region
Japan

Condition
Condition Malignant biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Technical feasibility and safety
Basic objectives2 Others
Basic objectives -Others Stent patency
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Technical feasibility and safety
Key secondary outcomes

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
Device,equipment
Interventions/Control_1 Radiofrequency ablation
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 Over 20years old
Malignant biliary stricture
Complicated with obstructive jaundice and advanced malignant tumor
Possibility of over 3months prognosis
PS0 to 2
Key exclusion criteria Patient's rejection
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Ogura
Organization Osaka Medical College
Division name 2nd Department of Internal Medicine
Zip code
Address 2-7 Daigakuchou, Takatsukishi, Osaka 569-8686, Japan
TEL 072-683-1221
Email oguratakeshi0411@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Ogura
Organization Osaka Medical College
Division name 2nd Department of Internal Medicine
Zip code
Address 2-7 Daigakuchou, Takatsukishi, Osaka 569-8686, Japan
TEL 072-683-1221
Homepage URL
Email oguratakeshi0411@yahoo.co.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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
2017 Year 03 Month 14 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
Date of protocol fixation
2007 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 14 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030476

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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