UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002206 |
|---|---|
| Receipt number | R000002714 |
| Scientific Title | Study on the effects of the through the scope type of the self-expandable metallic stent on the patients with the gastric outlet obstruction because of inoperable advanced cancer. |
| Date of disclosure of the study information | 2009/07/20 |
| Last modified on | 2012/02/08 14:33:42 |
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Basic information
Public title
Study on the effects of the through the scope type of the self-expandable metallic stent on the patients with the gastric outlet obstruction because of inoperable advanced cancer.
Acronym
Effect of the metallic stent on the gastric outlet obstruction.
Scientific Title
Study on the effects of the through the scope type of the self-expandable metallic stent on the patients with the gastric outlet obstruction because of inoperable advanced cancer.
Scientific Title:Acronym
Effect of the metallic stent on the gastric outlet obstruction.
Region
| Japan |
Condition
Condition
gastric outlet obstruction from gastric cancer, pancreatic cancer, biliary cancer, and metastatic cancer.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of metallic stent on the patients with gastric outlet obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success, clinical success, morbidty, hospital stay period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Maneuver |
Interventions/Control_1
group of the patients with metallic stent
Interventions/Control_2
group of the patients with by-pass operation
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
patients with gastric outlet obstruction due to advanced cancer
Key exclusion criteria
patients with more than PS4, patients with peritonitis carcinomatosa, patients with multiple obstruction of the GI truct
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Aiura |
Organization
keio University Hospital
Division name
Center for Diagnostic and Thrapeutic Endoscopy
Zip code
Address
Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Thrapeutic Endoscopy
Zip code
Address
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2009 | Year | 07 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 15 | Day |
Last modified on
| 2012 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002714
| 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 |
