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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023347
Receipt No. R000026904
Scientific Title A prospective study: the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant hilar biliary stricture.
Date of disclosure of the study information 2016/09/01
Last modified on 2016/07/26

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Basic information
Public title A prospective study: the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant hilar biliary stricture.
Acronym The efficacy of tapered balloon catheter for endoscopic multiple biliary stenting
Scientific Title A prospective study: the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant hilar biliary stricture.
Scientific Title:Acronym The efficacy of tapered balloon catheter for endoscopic multiple biliary stenting
Region
Japan

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

Objectives
Narrative objectives1 To review the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant biliary stricture patients who have already placed one or more metalic biliary stent.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Success rate of procedure (placing the additional biliary stent, passing a mesh of metalic stent using tapered balloon catheter)
Key secondary outcomes 1. Safety (the rate or severity of adverse effects)
2. Improving hepatobiliary laboratory data one day after procedure.

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 Using the tapered balloon catheter for endoscopic metalic biriary drainage
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 Malignant hilar biliary stricture patients who need multiple biliary drainage
Key exclusion criteria 1. Patients who are younger than 20 years old.
2. patients who present a difficult endoscopic approach due to gastrointestional obstruction.
3. Patients from whom informed concent cannot be obtained.
4. Patients who were performed abdominal surgery
Target sample size 45

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiromasa Ohira
Organization Fukushima Medical University
Division name Gastroenterology and Rheumatology
Zip code
Address 1, Hikarigaoka, Fukushima City
TEL 024-547-1202
Email h-ohira@fmu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mitsuru Sugimoto
Organization Fukushima Medical University
Division name Gastroenterology and Rheumatology
Zip code
Address 1, Hikarigaoka, Fukushima City
TEL 024-547-1202
Homepage URL
Email kita335@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
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
2016 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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
2016 Year 07 Month 26 Day
Last modified on
2016 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026904

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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