UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033692 |
|---|---|
| Receipt number | R000038413 |
| Scientific Title | Usefulness of a cannula with a flexible tip (Swing Tip) for managements of severe biliary strictures |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2019/08/10 09:53:51 |
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Basic information
Public title
Usefulness of a cannula with a flexible tip (Swing Tip) for managements of severe biliary strictures
Acronym
Usefulness of a cannula with a flexible tip (Swing Tip) for managements of severe biliary strictures
Scientific Title
Usefulness of a cannula with a flexible tip (Swing Tip) for managements of severe biliary strictures
Scientific Title:Acronym
Usefulness of a cannula with a flexible tip (Swing Tip) for managements of severe biliary strictures
Region
| Japan |
Condition
Condition
biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of using a Swing Tip for ERCP procedures.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who underwent ERCP using Swing Tips.
Key exclusion criteria
Patients who refused to participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho,Kita-ku,Okayama
TEL
086-235-7219
yksk-tkhk@k8.dion.ne.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Uchida |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho,Kita-ku,Okayama
TEL
086-235-7219
Homepage URL
d.uchida0309@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
| 2018 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.hindawi.com/journals/cjgh/2018/7125714/
Publication of results
Published
Result
URL related to results and publications
https://www.hindawi.com/journals/cjgh/2018/7125714/
Number of participants that the trial has enrolled
99
Results
A total of 99 patients (4.2%) underwent ERCP using the Swing Tip, including 49 patients for the selection of biliary branches and 50 for exchanging guidewires for rigid ones. In these patients, biliary stenting was successful in 22 patients (44.9%) and 45 patients (90%), respectively.There were no adverse events associated with the Swing Tip.
Results date posted
| 2019 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
2353 patients who had undergone
ERCP for biliary stenting because of biliary stenosis,
cholecystitis, or bile leakage after surgery between January　2012 and July 2018 at Okayama University Hospital.
Participant flow
The Swing Tip is usually used for accessing the biliary
branches if the procedure cannot be performed with any of these devices because of severe strictures or a crooked bile duct anatomy.
Adverse events
none
Outcome measures
technical success, clinical success, adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038413
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
