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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005052
Receipt No. 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

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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
Email

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
Email mifukuda258@nifty.com

Sponsor
Institute Nagasaki Municipal Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006006

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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