UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006785 |
|---|---|
| Receipt number | 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 | 2021/04/17 09:16:37 |
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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
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
khara@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
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
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008030
