UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050913 |
|---|---|
| Receipt number | R000058022 |
| Scientific Title | A retrospective clinical study of the utility of alpha-retroflex position in balloon enteroscope-assisted ERCP for patients with Roux-en Y gastrectomy |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/24 12:31:34 |
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Basic information
Public title
A retrospective clinical study of the utility of alpha-retroflex position in balloon enteroscope-assisted ERCP for patients with Roux-en Y gastrectomy
Acronym
A retrospective clinical study of the utility of alpha-retroflex position in balloon enteroscope-assisted ERCP for patients with Roux-en Y gastrectomy
Scientific Title
A retrospective clinical study of the utility of alpha-retroflex position in balloon enteroscope-assisted ERCP for patients with Roux-en Y gastrectomy
Scientific Title:Acronym
A retrospective clinical study of the utility of alpha-retroflex position in balloon enteroscope-assisted ERCP for patients with Roux-en Y gastrectomy
Region
| Japan |
Condition
Condition
Pancreaticobiliary pathology with Roux-en Y gastrectomy that balloon enteroscope-assisted ERCP was performed
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the outcome of cannulation strategy in balloon enteroscope-assiisted ERCP using alpha-position
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biliary cannulation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Roux-en Y gastrectomy who received balloon enteroscope-assisted ERCP was performed for pancreaticobiliary pathology
Key exclusion criteria
Patients with previous successful ERCP and pancreatic ERCP
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Imazu |
Organization
Nihon University Hospital
Division name
Gastroenterology
Zip code
101-8309
Address
1-6, Kanda-Surugadai, Ghiyoda-ku, Tokyo, Japan
TEL
+81-3-3293-1711
imazu.hiroo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Imazu |
Organization
Nihon University Hospital
Division name
Gastroeterology
Zip code
101-8309
Address
1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
+81-3-3293-1711
Homepage URL
imazu.hiroo@nihon-u.ac.jp
Sponsor or person
Institute
Nihon Universiity Hospital
Institute
Department
Personal name
Funding Source
Organization
Niihon University Hospital
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
Nihon University Hospiital
Address
1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
Tel
+81-3-3293-1711
imazu.hiroo@nihon-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
| 2023 | Year | 05 | 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
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basis information of research subjects, Method of biliary cannulation, image findings, rate of successful biliary cannulation and adverse event
Management information
Registered date
| 2023 | Year | 04 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058022
