UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058337 |
|---|---|
| Receipt number | R000066691 |
| Scientific Title | Use of an all-in-one sphincterotome with high rotation performance and freely bendable blade for Endoscopic Retrograde Cholangio-Pancreatography |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/01 18:10:41 |
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Basic information
Public title
Use of an all-in-one sphincterotome with high rotation performance and freely bendable blade for Endoscopic Retrograde Cholangio-Pancreatography
Acronym
Use of an all-in-one sphincterotome with high rotation performance and freely bendable blade for Endoscopic Retrograde Cholangio-Pancreatography
Scientific Title
Use of an all-in-one sphincterotome with high rotation performance and freely bendable blade for Endoscopic Retrograde Cholangio-Pancreatography
Scientific Title:Acronym
Use of an all-in-one sphincterotome with high rotation performance and freely bendable blade for Endoscopic Retrograde Cholangio-Pancreatography
Region
| Japan |
Condition
Condition
Billiary tract desease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the clinical utility and optimal usage techniques of a newly developed all-in-one sphincterotome, released in May 2024, which offers superior rotational capability and a highly flexible tip, in ERCP-related procedures performed not only in patients with surgically altered anatomy but also in those with normal anatomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of EST and the success rate of bile duct cannulation in native papilla.
Key secondary outcomes
Incidence of complications and the success rate of cannulation as a secondary device.
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
| 28 | years-old | <= |
Age-upper limit
| 91 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patientin which ERCP-related procedures were performed using all-in-one sphincterotome at Dokkyo Medical University Hospital between November 2023 and December 2024.
Key exclusion criteria
Cases in which consent to participate in the study was withdrawn after disclosure of information and cases in which the researcher determined that the patient was not excluded for this study.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yasuhito |
| Middle name | |
| Last name | Kunogi |
Organization
Dokkyo medical university School of medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282861111
ykunogi@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhito |
| Middle name | |
| Last name | Kunogi |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282861111
Homepage URL
ykunogi@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Dokkyo Medical University School of Medicine
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
0282861111
soumu@dokkyomed.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
| 2025 | Year | 07 | Month | 31 | 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
108
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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate the utility of an all-in-one sphincterotome in ERCP-related procedures.
Management information
Registered date
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066691
