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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006785
Receipt No. R000008030
Scientific Title Phase I/II study of EUS-HGS(EUS-guided hepaticogastrostomy) for malignant biliary tract obstruction
Date of disclosure of the study information 2011/11/28
Last modified on 2015/05/28

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Basic information
Public title Phase I/II study of EUS-HGS(EUS-guided hepaticogastrostomy) for malignant biliary tract obstruction
Acronym Phase I/II of EUS-HGS
Scientific Title Phase I/II study of EUS-HGS(EUS-guided hepaticogastrostomy) for malignant biliary tract obstruction
Scientific Title:Acronym Phase I/II of EUS-HGS
Region
Japan

Condition
Condition malignant biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and efficacy for EUS-HGS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
Key secondary outcomes

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 Maneuver
Interventions/Control_1 biliary obstruction
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
100 years-old >
Gender Male and Female
Key inclusion criteria 1. Biliary drainage required for distal biliary obstruction
caused by unresectable malignant tumor.
12. No tumor extension into the duodenal bulb or peri-bulbar
tissues.
3. Maintained major organ function marrow, heart, liver,
lungs, and kidneys. Absence of heart failure, platelet counts
4. Performance status (Eastern Cooperative Oncology Group):
0, 1, 2, or 3.
5.Predicted survival within 1 month.
6.Informed consent provided by the patient.
Key exclusion criteria 1.Malignant obstruction of the gastrointestinal tract.
2.Block of the upstream bile duct on the hepatic side.
3.Pregnancy.
4.History of local radiotherapy or planned radiotherapy
treatment of the tumor.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hara
Organization Aichi Cancer Center
Division name gastroenterology
Zip code
Address 1-1, kanokoden, tikusa-ku, Nagoya
TEL 052-762-6111
Email khara@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazuo hara
Organization Aichi Cancer Center
Division name Gastroenterology
Zip code
Address 1-1, kanokoden, Tikusa-ku, Nagoya, Japan
TEL 052-762-6111
Homepage URL
Email khara@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
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 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 11 Month 28 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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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 11 Month 28 Day
Last modified on
2015 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008030

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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