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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034043
Receipt No. R000038809
Scientific Title A prospective study of re-intervention with 12mm diameter biliary metallic stent for recurrent biliary obstruction
Date of disclosure of the study information 2018/09/10
Last modified on 2018/12/17

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Basic information
Public title A prospective study of re-intervention with 12mm diameter biliary metallic stent
for recurrent biliary obstruction
Acronym Revision study with 12mm covered self expandable metallic stent
Scientific Title A prospective study of re-intervention with 12mm diameter biliary metallic stent
for recurrent biliary obstruction
Scientific Title:Acronym Revision study with 12mm covered self expandable metallic stent
Region
Japan

Condition
Condition unresectable malignant distal biliary obstruction
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of re-intervention treatment using 12mm full-covered type self expandable metallic stent for the recurrent biliary obstruction in patients with unresectable distal biliary obstruction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to recurrent biliary obstruction after re-intervention
Key secondary outcomes Success rate of stent extraction, technical success rate, clinical success rate, associated factors with recurrent biliary obstruction after re-intervention

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 12mm full-covered type self expandable metallic stent
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. Unresectable malignant distal biliary obstruction
2. Prior biliary drainage with full-covered self expandable metallic stent whose diameter is less than 10mm
3. Complication of recurrent biliary obstruction that requires biliary drainage
4. More than 20 years old
5. Less than Grade 3 of performance status
6. Written informed consent obtained
Key exclusion criteria 1. Failure to extract the indwelling stent
2. Failure of biliary intervention after stent extraction
3. More than type 2 in Bismuth classification
4. Severe comorbilidity
5. Patients considered ineligible by attending physicians
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Tanaka
Organization Teine-Keijinkai Hospital
Division name Center for Gastroentelogy
Zip code
Address 1-40-1-12 Maeda, Teine-ku, Sapp oro, Hokkaido, 006-8555 Japan
TEL 011-681-8111
Email kazunari0511@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazunari Tanaka
Organization Teine-Keijinkai Hospital
Division name Center for Gastroentelogy
Zip code
Address 1-40-1-12 Maeda, Teine-ku, Sapp oro, Hokkaido, 006-8555 Japan
TEL 011-681-8111
Homepage URL
Email kazunari0511@gmail.com

Sponsor
Institute Center for Gastroenterology, Tein e-Keijinkai Hospital
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
2018 Year 09 Month 10 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 10 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
2018 Year 09 Month 05 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038809

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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