UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040509 |
|---|---|
| Receipt number | R000046242 |
| Scientific Title | Observational study of early precut for bile duct access in wire-guided cannulation. |
| Date of disclosure of the study information | 2020/05/26 |
| Last modified on | 2021/03/01 22:27:50 |
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Basic information
Public title
Observational study of early precut for bile duct access in wire-guided cannulation.
Acronym
Evaluation of early precut algorithm
Scientific Title
Observational study of early precut for bile duct access in wire-guided cannulation.
Scientific Title:Acronym
Evaluation of early precut algorithm
Region
| Japan |
Condition
Condition
Biliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate early precutting at a 5-minute limit during wire-guided cannulation.
Basic objectives2
Others
Basic objectives -Others
To evaluate biliary accessibility and adverse events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biliary accessibility and predictors
Key secondary outcomes
Adverse events and risk factors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Naive papilla
Patients who underwent biliary intervention
Key exclusion criteria
Not naive papilla
Reconstructed anatomy
Intervention for the pancreas
Algorithm deviation
Vater's tumor
Direct precut
Intervention through antegrade hepaticogastrostomy route
Target sample size
298
Research contact person
Name of lead principal investigator
| 1st name | TESSHIN |
| Middle name | |
| Last name | BAN |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology
Zip code
889-9602
Address
5200 Kihara, Kiyotake, Miyazaki, 889-9602
TEL
0985-85-9797
venzosan0204@gmail.com
Public contact
Name of contact person
| 1st name | TESSHIN |
| Middle name | |
| Last name | BAN |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology
Zip code
889-9602
Address
5200 Kihara, Kiyotake, Miyazaki, 889-9602
TEL
0985-85-9797
Homepage URL
venzosan0204@gmail.com
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, 889-9602
Tel
0985859797
venzosan0204@gmail.com
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
| 2020 | Year | 05 | Month | 26 | 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
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046242
