UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective study of stent-in-stent deployment using novel uncovered stent for malignant hilar obstruction
Acronym	Multicenter prospective study of stent-in-stent deployment using novel uncovered stent for malignant hilar obstruction
Scientific Title	Multicenter prospective study
Scientific Title:Acronym	Multicenter prospective study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate technical feasibility of stent deployment without any dilation using HIRZO stent
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical feasibility
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	Maneuver
Interventions/Control_1	HIRZO 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	Over 20 years Malignant hepatic hilar obstruction with histological evidence Bismuth classification II, III, IV ECOG(Eastern Cooperative Oncology Group) performance status 0-3 Informed content
Key exclusion criteria	Inaccessible papilla Over ASA3 Over ECOG 4 Poor prognosis (3 months)
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Ogura
Organization	Osaka Medical College
Division name	2nd Department of Internal Medicine
Zip code	5698686
Address	2-7 Daigakumachi Takatsukishi
TEL	072-683-1221
Email	oguratakeshi0411@yahoo.co.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Ogura
Organization	Osaka Medical College
Division name	2nd Department of Internal Medicine
Zip code	5698686
Address	2-7 Daigakumachi Takatsukishi
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	Osaka Medical College
Address	2-7 Daigakumachi Takatsukishi
Tel	072-683-1221
Email	rinri@osaka-med.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 07 Month 11 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 02 Month 25 Day
Date of IRB	2019 Year 05 Month 24 Day
Anticipated trial start date	2019 Year 05 Month 26 Day
Last follow-up date	2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 10 Day
Last modified on	2019 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041971