UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030201 |
|---|---|
| Receipt number | R000034500 |
| Scientific Title | The Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2017/11/30 21:01:17 |
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Basic information
Public title
The Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures
Acronym
M-FCSEMS in periampullary malignant biliary stricture
Scientific Title
The Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures
Scientific Title:Acronym
M-FCSEMS in periampullary malignant biliary stricture
Region
| Asia(except Japan) |
Condition
Condition
under IRB
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of newly modified non-flared FCSEMS (M-FCSEMS) having 12mm in diameter to minimized stent migration compared with the conventional FCSEMS in patients with periampullary MBS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent migration rate in periampullary malignant biliary stricture
Key secondary outcomes
-Technical success rate
-Clinical success rate
-Other adverse events
-Stent occlusion and re-intervention rate
-Stent patency
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ERCP with biliary drainage of newly modified non-flared FCSEMS(BONASTENT M-intraductal 12)
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age at least 18 years
2)Periampullary cancer; ampulla of Vater cancer, distal CBD cancer, pancreatic head cancer
3)Clinical symptoms of biliary obstruction with obstructive jaundice and/or cholangitis
Key exclusion criteria
1)Surgically altered anatomy
2)Bleeding tendency (INR > 1.5 or platelet count < 50,000/mm3)
3)Contraindications for ERCP
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jong Ho Moon |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute
Zip code
Address
170 Jomaru-ro, Bucheon-si, Gyeonggi-do, Korea
TEL
+821087153543
jhmoon@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyun Woo Lee |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute
Zip code
Address
170 Jomaru-ro, Bucheon-si, Gyeonggi-do, Korea
TEL
+821080235271
Homepage URL
imlhw@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
Institute
Department
Personal name
Funding Source
Organization
SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
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
| 2017 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034500
| 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 |
