UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013653 |
|---|---|
| Receipt number | R000015401 |
| Scientific Title | Covered versus uncovered metallic stents for palliation of malignant gastric outlet obstruction: A multicenter randomized trial. |
| Date of disclosure of the study information | 2014/04/07 |
| Last modified on | 2014/04/07 12:20:51 |
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Basic information
Public title
Covered versus uncovered metallic stents for palliation of malignant gastric outlet obstruction: A multicenter randomized trial.
Acronym
Covered versus uncovered metallic stents for palliation of malignant gastric outlet obstruction: A multicenter randomized trial.
Scientific Title
Covered versus uncovered metallic stents for palliation of malignant gastric outlet obstruction: A multicenter randomized trial.
Scientific Title:Acronym
Covered versus uncovered metallic stents for palliation of malignant gastric outlet obstruction: A multicenter randomized trial.
Region
| Japan |
Condition
Condition
Unresectable malignant tumor causing gastric outlet obstruction
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate superiolity of covered metal stent to uncovered metal stent for gastric outlet obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to stent dysfunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
| Device,equipment |
Interventions/Control_1
Covered metal stent
Interventions/Control_2
Uncovered 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients of GOO score <=1.
2)Patients with symptoms due to GOO.
3)Patients with GOO confirmed under gastroduodenoscopy.
4)Patients with malignant tumors confirmed pathologically.
5)Patients with unresectable malignant tumors.
6)Patients whose performance status is less than 3.
7)Patients who agreed with the voluntary participation in the study.
Key exclusion criteria
1) Patients who had jejunal or distal obstructions due to primary disease
2) Patients who had multiple levels of obstruction or peristalsis dysfunction due to carcinomatous peritonitis.
3) Patients with the substantial ascites.
4) Patients who previously received surgical or medical treatment.
5) Patients on whom endoscopic examination could not be performed.
6) Patients whose informed consent we could not obtain.
7) Inappropriate patients whom the investigators judge eligible.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kawamoto |
Organization
Kawasaki Medical School
Division name
General Internal Medicine 2
Zip code
Address
2-1-80,Nakasange,Kita-ku,Okayama
TEL
086-225-2111
hirofumi.kawamoto@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kawamoto |
Organization
Kawasaki Medical School
Division name
General Internal Medicine 2
Zip code
Address
2-1-80,Nakasange,Kita-ku,Okayama
TEL
086-225-2111
Homepage URL
hirofumi.kawamoto@gmail.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
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 | 04 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2014 | Year | 04 | Month | 07 | Day |
Last modified on
| 2014 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015401
