UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008612 |
|---|---|
| Receipt number | R000010125 |
| Scientific Title | Endoscopic ultrasound-guided rendezvous technique (EUS-RV) for difficult biliary cannulation: a multicenter pilot study to evaluate efficacy and safety |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2013/12/26 17:03:43 |
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Basic information
Public title
Endoscopic ultrasound-guided rendezvous technique (EUS-RV) for difficult biliary cannulation:
a multicenter pilot study to evaluate efficacy and safety
Acronym
A multicenter pilot study of EUS-RV
Scientific Title
Endoscopic ultrasound-guided rendezvous technique (EUS-RV) for difficult biliary cannulation:
a multicenter pilot study to evaluate efficacy and safety
Scientific Title:Acronym
A multicenter pilot study of EUS-RV
Region
| Japan |
Condition
Condition
biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of EUS-RV for cases in whom selective deep cannulation into the bile duct prior to therapeutic ERCP was failed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Technical success rate
Key secondary outcomes
Complication rate
Clinical success rate
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
Therapeutic ERCP
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)patients need therapeutic ERCP
2)performance status of 0-3
3)life expectancy more than 4 weeks
4)written informed consent obtained from the patient
Key exclusion criteria
1)severe bleeding tendency
2)severe cardiac disease, severe pulmonary disease, severe renal disease
3)impaired consciousness
4)pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Gifu, Japan
TEL
058-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuji Iwashita |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yangito, Gifu
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
1)Gifu Municipal Hospital
2)Gifu Prefectural General Medical Center
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
| 2012 | Year | 08 | Month | 08 | 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
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 08 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2013 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010125
