UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006345 |
|---|---|
| Receipt number | R000007327 |
| Scientific Title | Endoscopic treatment of malignant bile duct stricture; Comparative study of conventional stent vs inside stent |
| Date of disclosure of the study information | 2011/09/14 |
| Last modified on | 2016/03/14 17:58:52 |
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Basic information
Public title
Endoscopic treatment of malignant bile duct stricture; Comparative study of conventional stent vs inside stent
Acronym
Comparative study of endoscopic stent placement
Scientific Title
Endoscopic treatment of malignant bile duct stricture; Comparative study of conventional stent vs inside stent
Scientific Title:Acronym
Comparative study of endoscopic stent placement
Region
| Japan |
Condition
Condition
malignant diliary stricuture (bile duct cancer)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
this study is to evaluate the risk of reflux cholangitis after stent placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the period from the stent placement to stent 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
| Device,equipment |
Interventions/Control_1
conventional tube stent (Amsterdam type or Tannenbaum type)
Interventions/Control_2
conventional tube stent (Amsterdam type or Tannenbaum type) with nylon thread tied to the stent via the distal hole.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
malignant biliary stricture cases with radical resection after chemoradiotheraphy
Key exclusion criteria
malignant biliary stricuture cases with obstructive icterus or cholangitis uncontrolable with endoscopic treatment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kobayashi noritoshi |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL
045-787-2800
norikoba@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kobayashi Noritoshi |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
Address
3-9 Fuku-ura Kanazawaku Yokohama City
TEL
045-787-2800
Homepage URL
norikoba@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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 | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2004 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 09 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 09 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 14 | Day |
Last modified on
| 2016 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007327
