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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021379
Receipt No. R000024657
Scientific Title Evaluation of the efficacy and safety of endoscopic-ultrasound guided rendezvous technique using a small diameter needle for failed selective biliary deep canulation
Date of disclosure of the study information 2016/03/08
Last modified on 2016/03/18

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Basic information
Public title Evaluation of the efficacy and safety of endoscopic-ultrasound guided rendezvous technique using a small diameter needle for failed selective biliary deep canulation
Acronym Evaluation of the efficacy and safety of endoscopic-ultrasound guided rendezvous technique
Scientific Title Evaluation of the efficacy and safety of endoscopic-ultrasound guided rendezvous technique using a small diameter needle for failed selective biliary deep canulation
Scientific Title:Acronym Evaluation of the efficacy and safety of endoscopic-ultrasound guided rendezvous technique
Region
Japan

Condition
Condition Cases with failed selective biliary deep cannulation by ERCP
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of endoscopic ultrasound-guided rendezvous technique as a salvage method using a small diameter needle for failed selective biliary deep cannulation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Technical success rate of endoscopic ultrasound-guided rendezvous technique
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients in whom biliary deep cannulation cannot be achieved with ERCP.
2)Patients consent to be included in this study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria 1)Patients with endoscopically inaccessible to the papilla or the anastomosis site
2)Patients whose performance status are 4.
3)Patients with sever complication in other organs except original disease.
4)Cases judged by principal investigator to be unsuitable as subjects.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Email m-kitano@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Minaga
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Homepage URL
Email kousukeminaga@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 03 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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study (cohort study)

This study aims to evaluate the efficacy and safety of endoscopic-ultrasound guided rendezvous technique using a small diameter needle for failed selective biliary deep cannulation. The primary outcome is the technical success rate of biliary deep cannulation. The secondary outcomes are procedure time and adverse events.

The target of this study is a patient with pancrtatobiliary disease in whom failed selective biliary deep cannulation visited our hospital between 2016 March and 2018 March.

Management information
Registered date
2016 Year 03 Month 07 Day
Last modified on
2016 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024657

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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