UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005052 |
|---|---|
| Receipt number | R000006006 |
| Scientific Title | Stenting for Malignant Superior Vena Cava Syndrome |
| Date of disclosure of the study information | 2011/02/09 |
| Last modified on | 2011/02/08 17:08:54 |
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Basic information
Public title
Stenting for Malignant Superior Vena Cava Syndrome
Acronym
Stenting for SVC syndrome
Scientific Title
Stenting for Malignant Superior Vena Cava Syndrome
Scientific Title:Acronym
Stenting for SVC syndrome
Region
| Japan |
Condition
Condition
Supra Vena Cava Syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of stenting for supra vena cava syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Efficacy
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
| Device,equipment |
Interventions/Control_1
Stenting in venous stenosis
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. stenosis of supra or inferior vena cava with symptom
2. unable to control the symptom by drug including diuretic agents
3. adequate organ function: no heart failure, WBC≥3000/mm3, Hb≥8.0g/dl, Plt≥50000/mm3, T-Bil≤3.0mg/dl, sCr≤2.0mg/dl, ECG W.N.L, PS 0-3
4. expective to survive longer than 4 weeks
5. written informed consent
Key exclusion criteria
1. tumor embolism in the vein
2. suspended thrombus in the peripherally stenosis
3. pulmonary embolism
4. severe cardiac dysfunction
5. both stenosis with supra and inferionr vena cava
6. with active infection
7. with acute hemorrhagic lesion
8. inadequate determinated case by attending physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Fukuda |
Organization
Nagasaki Municipal Hospital
Division name
Internal Medicine
Zip code
Address
6-39 Shinchi, Nagasaki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Fukuda |
Organization
Nagasaki Municipal Hospital
Division name
Internal Medicine
Zip code
Address
TEL
Homepage URL
mifukuda258@nifty.com
Sponsor or person
Institute
Nagasaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Municipal Hospital
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
| 2011 | Year | 02 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | 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
| 2011 | Year | 02 | Month | 08 | Day |
Last modified on
| 2011 | 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=R000006006
