UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031051 |
|---|---|
| Receipt number | R000035053 |
| Scientific Title | Phase I/II study of EUS-HES(EUS-guided hepaticoenterostomy) for malignant biliary hilar stenosis |
| Date of disclosure of the study information | 2018/01/29 |
| Last modified on | 2022/08/03 12:02:39 |
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Basic information
Public title
Phase I/II study of EUS-HES(EUS-guided hepaticoenterostomy) for malignant biliary hilar stenosis
Acronym
Phase I/II study of EUS-HES for malignant biliary hilar stenosis
Scientific Title
Phase I/II study of EUS-HES(EUS-guided hepaticoenterostomy) for malignant biliary hilar stenosis
Scientific Title:Acronym
Phase I/II study of EUS-HES for malignant biliary hilar stenosis
Region
| Japan |
Condition
Condition
malignant biliary hilar stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of EUS-HES for malignant biliary hilar stenosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Clinical efficacy
Key secondary outcomes
Rate of adverse events
Grade of adverse events
Re-intervention
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
biliary drainage
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.Biliary drainage required for biliary hilar obstruction secondary to unresectable malignant tumor
2.No tumor extension into the puncture site
3.Maintenance of major organ function
4.Informed consent provided by the patient.
Key exclusion criteria
1.Not primary drainage
2.Massive hilar invasion
3.With cholangitis
4.Pregnant
5.Easy bleeding
6.Doctor disagree
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center Hospital
Division name
Gastroenterology
Zip code
4648681
Address
1-1, kanokoden, chikusa-ku,Nagoya
TEL
052-762-611
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Okuno |
Organization
Aichi Cancer Center Hospital
Division name
Gastroenterology
Zip code
4648681
Address
1-1, kanokoden, chikusa-ku,Nagoya
TEL
052-762-611
Homepage URL
nokuno@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
1-1, kanokoden, chikusa-ku,Nagoya
Tel
052-762-6111
irb@aichi-cc.jp
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
| 2018 | Year | 01 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035053
