UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021379 |
|---|---|
| Receipt number | 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 14:23:46 |
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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
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
kousukeminaga@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024657
