UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001708 |
|---|---|
| Receipt number | R000002062 |
| Scientific Title | Combined endoscopic stent-in-stent placement for malignant biliary and duodenal obstruction using a new duodenal metal stent |
| Date of disclosure of the study information | 2009/02/13 |
| Last modified on | 2009/02/13 21:27:44 |
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Basic information
Public title
Combined endoscopic stent-in-stent placement for malignant biliary and duodenal obstruction using a new duodenal metal stent
Acronym
Enteral metal stent for double stenting malignant bilioduodenal strictures
Scientific Title
Combined endoscopic stent-in-stent placement for malignant biliary and duodenal obstruction using a new duodenal metal stent
Scientific Title:Acronym
Enteral metal stent for double stenting malignant bilioduodenal strictures
Region
| Asia(except Japan) |
Condition
Condition
malignant bilioduodenal strictures
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and clinical success rate of endoscopic double stent-in-stent placement using a new duodenal metallic stent for the management of malignant biliary and duodenal obstructions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Technical and clinical success
Key secondary outcomes
complications
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
| Maneuver |
Interventions/Control_1
endoscopic double stent-in-stent placement
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Unresectable malignant bilioduodenal strictures.
2) Symptoms of biliary and gastric outlet obstruction
Key exclusion criteria
1) Bleeding tendency (INR>1.5, platelet<50,000/ml)
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jong Ho Moon |
Organization
Soon Chun Hyang University School of Medicine, Bucheon Hospital
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea
TEL
+82-32-621-5094
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jong Ho Moon |
Organization
Soon Chun Hyang University School of Medicine, Bucheon Hospital
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea
TEL
+82-32-621-5094
Homepage URL
jhmoon@schbc.ac.kr
Sponsor or person
Institute
Digestive Disease Center, Department of Internal Medicine,
Soon Chun Hyang University School of Medicine, Bucheon, Korea
Institute
Department
Personal name
Funding Source
Organization
No
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
| 2009 | Year | 02 | Month | 13 | 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
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 13 | Day |
Last modified on
| 2009 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002062
