UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004758 |
|---|---|
| Receipt number | R000005664 |
| Scientific Title | A Prospective Study of Uncovered Metallic Stent for unresectable malignant intrahepatic, hilar and upper biliary stricture |
| Date of disclosure of the study information | 2011/06/11 |
| Last modified on | 2013/12/16 14:50:37 |
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Basic information
Public title
A Prospective Study of Uncovered Metallic Stent for unresectable malignant intrahepatic, hilar and upper biliary stricture
Acronym
A Prospective Study of Metallic Stent for unresectable malignant intrahepatic, hilar and upper biliary stricture
Scientific Title
A Prospective Study of Uncovered Metallic Stent for unresectable malignant intrahepatic, hilar and upper biliary stricture
Scientific Title:Acronym
A Prospective Study of Metallic Stent for unresectable malignant intrahepatic, hilar and upper biliary stricture
Region
| Japan |
Condition
Condition
Unresectable malignant intrahepatic, hilar and upper biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical efficacy of Uncovered Metallic Stent for unresectable intrahepatic, hilar and upper malignant biliary stricture
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency period
Successful rate
Key secondary outcomes
Stent occlusion rate, Stent-related complication rate, Event free survival, overall survival
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
BILE RUSH Uncocered Metallic Stent
FLEXXUS Uncocered Metallic Stent etc.
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
:Unresectable intrahepatic, hilar and upper malignant biliary obstruction
:Not limited by primary disease, age, and sex
:Patients with written informed consent
Key exclusion criteria
:Patients for whom endoscopic biliary drainage is difficult.
:Tendency of bleeding
:Patients with severely impaired organ
function
:Patients without written informed consent
:Patients considered ineligible for this
study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio TSUYUGUCHI |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji SAKAI |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
Homepage URL
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
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
| 2011 | Year | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
Nothing particular
Management information
Registered date
| 2010 | Year | 12 | Month | 20 | Day |
Last modified on
| 2013 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005664
