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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036315
Receipt No. R000041358
Scientific Title Efficacy of inside plastic stent placement for malignant hilar biliary obstruction -multicenter, randomized control trial-
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/27

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Basic information
Public title Efficacy of inside plastic stent placement for malignant hilar biliary obstruction -multicenter, randomized control trial-
Acronym Efficacy of inside stent placement for mmalignant hilar biliary obstruction
Scientific Title Efficacy of inside plastic stent placement for malignant hilar biliary obstruction -multicenter, randomized control trial-
Scientific Title:Acronym Efficacy of inside stent placement for mmalignant hilar biliary obstruction
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of inside plastic stent placement for malignant hilar biliary obstruction compared to across
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to recurrent biliary obstruction
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Compare the methods of biliary stent placement
Across the papilla vs above the papilla
Interventions/Control_2 Above the papilla
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 malignant hilar biliary obstruction
2 Unresectable malignant tumor
3 The malignant tumor was confirmed by pathoological examination or obviously diagnosed by the images
4 Need to drainage for obstructive jaundice
Key exclusion criteria 1 Difficult to access the biliary duct by endoscopy
2 Patients have previously recieved upper GI reconstruction.
3 benign obstruction
4 pregnancy
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Isayama
Organization Juntendo University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku Tokyo Japan
TEL 0358021060
Email h-isayama@juntendo.ac.jp

Public contact
Name of contact person
1st name Toshio
Middle name
Last name Fujisawa
Organization Juntendo University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku Tokyo Japan
TEL 0358021060
Homepage URL
Email t-fujisawa@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization Juntendo University Graduate School of Medicine
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 Juntendo University Hospital
Address 3-1-3 Hongo, Bunkyo-ku Tokyo Japan
Tel 0338133111
Email kenkyu5858@juntendo.ac.jp

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
2019 Year 04 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
2019 Year 03 Month 19 Day
Date of IRB
2019 Year 03 Month 25 Day
Anticipated trial start date
2019 Year 06 Month 30 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041358

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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