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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007529
Receipt No. 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

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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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoundo Hospital
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email yashimay@gmail.com

Sponsor
Institute Kyoundo Hospital, Gastroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008891

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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