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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008612
Receipt No. 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

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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
Email 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
Email takuji-guh@umin.ac.jp

Sponsor
Institute Gifu University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010125

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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