UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030544 |
|---|---|
| Receipt number | R000034871 |
| Scientific Title | EUS-guided hybrid rendezvous technique as salvage for standard rendezvous |
| Date of disclosure of the study information | 2017/12/24 |
| Last modified on | 2021/07/03 11:15:31 |
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Basic information
Public title
EUS-guided hybrid rendezvous technique as salvage for standard rendezvous
Acronym
EUS-HRV
Scientific Title
EUS-guided hybrid rendezvous technique as salvage for standard rendezvous
Scientific Title:Acronym
EUS-HRV
Region
| Japan |
Condition
Condition
biliary tract diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of hybrid-rendezvous technique in cases with difficult guidewire placement during EUS-rendezvous technique with intrahepatic bile duct approach
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of hybrid rendezvous
Key secondary outcomes
Safety of hybrid rendezvous technique
Influence of hybrid rendezvous technique with the success rate of rendezvous technique
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who underwent EUS-hybrid rendezvous as salvage for difficult biliary cannulation.
Key exclusion criteria
Patients who had management combined with percutaneous procedure or surgical procedure were excluded
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Iwashita |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
takuji-guh@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuji Iwashita |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
Homepage URL
takuji-guh@umin.ac.jp
Sponsor or person
Institute
Gifu University Hospital
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
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
| 2017 | Year | 12 | Month | 24 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation was finished.
Management information
Registered date
| 2017 | Year | 12 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034871
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
