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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039254
Receipt No. R000044764
Scientific Title Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Date of disclosure of the study information 2020/01/24
Last modified on 2020/01/24

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Basic information
Public title Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Acronym Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Scientific Title Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Scientific Title:Acronym Prospective evaluation of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the feasibility and efficacy of the novel multi-stenting technique for high-grade malignant hilar biliary obstruction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Technical success rate
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patient with high-grade unresectable malignant hilar biliary obstruction which require biliary drainage
Key exclusion criteria 1) Patients having difficulty in transpapillary approach
2) Patients with surgically altered anatomy
3) Re-intervention
4) Ptients with small diameter common bile duct
5) Patients with performance status 4
6) Patients with severe comorbiditeis in any other organs
7) Pregnant women or those suspected of pregnancy
8) Patients without informed consent
9) Inappropriate patients for entry on this study in the judgement of their research investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tadahisa
Middle name
Last name Inoue
Organization Aichi Medical University
Division name Department of Gastroenterology
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561623311
Email tinoue-tag@umin.ac.jp

Public contact
Name of contact person
1st name Tadahisa
Middle name
Last name Inoue
Organization Aichi Medical University
Division name Department of Gastroenterology
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561623311
Homepage URL
Email tinoue-tag@umin.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi 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 Aichi Medical University
Address 1-1 Yazakokarimata Nagakute Aichi
Tel 0561623311
Email kanrika@aichi-med-u.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
2020 Year 01 Month 24 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
2019 Year 12 Month 25 Day
Date of IRB
2020 Year 01 Month 21 Day
Anticipated trial start date
2020 Year 01 Month 24 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the effeicacy and safety of a novel multi-stenting technique for high-grade malignant hilar biliary obstructions

Management information
Registered date
2020 Year 01 Month 24 Day
Last modified on
2020 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044764

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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