UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013032 |
|---|---|
| Receipt number | R000015210 |
| Scientific Title | The Usefulness of the expandable metallic partial covered stent (PCMS) for patients with malignant biliary stricture |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2014/01/31 13:28:35 |
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Basic information
Public title
The Usefulness of the expandable metallic partial covered stent (PCMS) for patients with malignant biliary stricture
Acronym
The Usefulness of the PCMS for patients with malignant biliary stricture
Scientific Title
The Usefulness of the expandable metallic partial covered stent (PCMS) for patients with malignant biliary stricture
Scientific Title:Acronym
The Usefulness of the PCMS for patients with malignant biliary stricture
Region
| Japan |
Condition
Condition
malignant biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to validate one step method of PCMS for pts with malignant biliary stricture
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
success rate of endoscopic stent placement, complication and cost.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Two group;
one step group is PCMS first.
two step group is plastic stent followed PCMS
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.no history of endoscopic stent placement
2.age over 20 year old
3.Performance status(ECOG)0,1or2
4.informed consent
Key exclusion criteria
tendency for bleeding
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kensuke kubota |
Organization
Yokohama City University Hospital
Division name
Endoscopic unit
Zip code
Address
3-9 Fukuura,Yokohma
TEL
045-787-2800
kubotak@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | saito satosi |
Organization
Yokohama City Universsity
Division name
Gastroeneterology
Zip code
Address
3-9 Fukuura,Yokohama
TEL
045-787-2800
Homepage URL
kubotak@yokohma-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City 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
| 2014 | Year | 02 | Month | 01 | 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
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 31 | Day |
Last modified on
| 2014 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015210
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