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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017140
Receipt No. R000018968
Scientific Title A multicenter exploratory study on the usefulness of covered metalic stent with fins(New GENOS) for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors
Date of disclosure of the study information 2015/04/14
Last modified on 2015/04/14

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Basic information
Public title A multicenter exploratory study on the usefulness of covered metalic stent with fins(New GENOS) for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors
Acronym A multicenter exploratory study on the usefulness of New GENOS
Scientific Title A multicenter exploratory study on the usefulness of covered metalic stent with fins(New GENOS) for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors
Scientific Title:Acronym A multicenter exploratory study on the usefulness of New GENOS
Region
Japan

Condition
Condition Middle-lower bile duct obstruction caused by malignant tumors such as pancreas cancer, Ampullary carcinoma, bile duct cancer, gallbladder cancer, malignant lymphoma, lymph node metastasis, etc
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the patency and safety of Covered Metallic Stent(CMS) with fins(New GENOS)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of stent migration
Key secondary outcomes rate of recurrent biliary obstruction(RBO), time to recurrent biliary obstruction(TRBO)

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 placement New GENOS stent to non-resectable distal malignant biliary obstruction
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 non-resectable distal malignant
biliary obstruction
Written informed consent was obtained
from all patients before the procedures
Key exclusion criteria difficult to approach by endoscope
Patients with ascites
Patients with hilar obstruction
World Health Organization performance status of 4
Target sample size 35

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655
TEL 81-3-3815-5411
Email isayama-tky@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kazunaga Ishigaki
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8655
TEL 81-3-3815-5411
Homepage URL
Email ISHIGAKIKA-INT@h.u-tokyo.ac.jp

Sponsor
Institute Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
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
2015 Year 04 Month 14 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
2014 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 10 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
2015 Year 04 Month 14 Day
Last modified on
2015 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018968

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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