UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007529 |
|---|---|
| Receipt number | R000008891 |
| Scientific Title | Feasibility Study of Endosonoscopic ethanol injection therapy to metastatic lesion. |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2012/03/19 11:19:38 |
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Basic information
Public title
Feasibility Study of Endosonoscopic ethanol injection therapy to metastatic lesion.
Acronym
Feasibility study of EUS-FI
Scientific Title
Feasibility Study of Endosonoscopic ethanol injection therapy to metastatic lesion.
Scientific Title:Acronym
Feasibility study of EUS-FI
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of endosonographic ethanol injection therapy to metastatic lesion of carcinma, mainly hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of therapy will be evaluated by tumor size and tumor markars.
Key secondary outcomes
safety
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
We will inject ethanol into the malignant lesion using endosography.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Age over 20-years-old.
2 Patient with advanced carcinoma.
3 Patient whose rimary lesion is under contraol by current therapy, but have metastatic lesion not contraolled by standard thrapy located not reaced transabdominal approach.
4 Patients with performance status 0 or 1.
5 Patients who can understand on their own and write written consent.
Key exclusion criteria
1 Patients whose metastatic lesion is not observed by endosonography.
2 Patients not appliacable to stop of anticoagulation.
3 Patients who bleed easily.
4 Patients doctors think not apparoproatedy. for this stu
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Yashima |
Organization
Kyoundo Hospital
Division name
Gastroenterology
Zip code
Address
1-8, Kandasurugadai, Chiyoda-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoundo Hospital
Division name
Gastroenterology
Zip code
Address
TEL
Homepage URL
yashimay@gmail.com
Sponsor or person
Institute
Kyoundo Hospital, Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
YES
Study ID_1
2012-1
Org. issuing International ID_1
Kyoundo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杏雲堂病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 03 | Month | 19 | Day |
Last modified on
| 2012 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008891
