UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042805 |
|---|---|
| Receipt number | R000048856 |
| Scientific Title | Validation study of the efficacy and safety of first precutting for Oral protrusion-Large, which is difficult to biliary duct cannulation. |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2023/06/27 07:57:53 |
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Basic information
Public title
Validation study of the efficacy and safety of first precutting for Oral protrusion-Large, which is difficult to biliary duct cannulation.
Acronym
Validation study of the efficacy and safety of first precutting for Oral protrusion-Large, which is difficult to biliary duct cannulation.
Scientific Title
Validation study of the efficacy and safety of first precutting for Oral protrusion-Large, which is difficult to biliary duct cannulation.
Scientific Title:Acronym
Validation study of the efficacy and safety of first precutting for Oral protrusion-Large, which is difficult to biliary duct cannulation.
Region
| Japan |
Condition
Condition
Cases requiring ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validation of the efficacy and safety of first precutting for Oral protrusion-Large, which is difficult to biliary duct cannulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of post-ERCP pancreatitis
Key secondary outcomes
Success rate of biliary duct cannulation
Rate of oral protrusion pattern
Adverse event
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
Cases requiring ERCP
Naive papilla
Papilla of Oral protrusion-Large
Key exclusion criteria
Previously treated duodenal papilla
ERCP for pancreatic duct cannulation
Papilla cannot judge Oral protrusion pattern
Bleeding tendency
Patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
042-778-8111
m.wata@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
042-778-8111
Homepage URL
m.wata@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
Kitasato University school of medicine, Institutional Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
Tel
042-778-8111
rinrib@med.kitasato-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
| 2021 | Year | 01 | Month | 01 | 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
38
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items:
1 Patient characteristics
2 ERCP results and adverse events
Management information
Registered date
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048856
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
