UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013276 |
|---|---|
| Receipt number | R000015475 |
| Scientific Title | A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study |
| Date of disclosure of the study information | 2014/03/08 |
| Last modified on | 2015/12/14 18:51:31 |
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Basic information
Public title
A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study
Acronym
A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study
Scientific Title
A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study
Scientific Title:Acronym
A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-Diameter with Long Lasso for Intraductal Placement in Patients with Malignant Biliary Stricture: Feasibility Study
Region
| Asia(except Japan) |
Condition
Condition
malignant biliary stricture (MBS)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of newly modified, non-flared FCSEMS having 12mm in diameter with long lasso for intraductal placement in patients with MBS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency
Key secondary outcomes
The rates of technical and clinical success
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
fully covered self-expandable metallic stent (FCSEMS)-M-intraductal
Interventions/Control_2
partial covered self-expandable metal stent
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patients with inoperable distal malignant biliary strictures
2) patients with malignant biliary strictur comfirmed histopathologically
3) patients with proximal border of malignant biliary stricture thatis far from hilar at least 2cm away
Key exclusion criteria
1) Coagulopathy (PT-INR > 1.5, normal 0.85-1.25 or platelet count < 80,000/mm3, normal 150,000-450,000/mm3)
2) Performance status < 3 (scales of the Eastern Cooperative Oncology Group)
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jong Ho Moon |
Organization
Digestive Disease Center and Research Institute, Department of Internal Medicine,
Soon Chun Hyang University School of Medicine, Bucheon and Seoul, Korea
Division name
Gastroenterology
Zip code
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL
+82-32-621-5094
jhmoon@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yun Nah Lee |
Organization
Digestive Disease Center and Research Institute, Department of Internal Medicine,
Division name
Gastroenterology
Zip code
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL
+82-32-621-5094
Homepage URL
yunnah@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University
Institute
Department
Personal name
Funding Source
Organization
SoonChunHyang University Research Fund
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 03 | Month | 08 | 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
Suspended
Date of protocol fixation
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 10 | 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
| 2014 | Year | 02 | Month | 25 | Day |
Last modified on
| 2015 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015475
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
