UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049892 |
|---|---|
| Receipt number | R000056824 |
| Scientific Title | Study of a new method (direct visual ON method) to ensure mouth to nose transition during endoscopic nasobiliary drainage (ENBD) tube placement |
| Date of disclosure of the study information | 2022/12/25 |
| Last modified on | 2023/06/28 00:17:10 |
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Basic information
Public title
Study of a new method (direct visual ON method) to ensure mouth to nose transition during endoscopic nasobiliary drainage (ENBD) tube placement
Acronym
ON method study for ENBD
Scientific Title
Study of a new method (direct visual ON method) to ensure mouth to nose transition during endoscopic nasobiliary drainage (ENBD) tube placement
Scientific Title:Acronym
ON method study for ENBD
Region
| Japan |
Condition
Condition
Patients scheduled for ENBD placement
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verify the safety and versatility of the direct visual ON method for ENBD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of the direct visual ON method during ENBD implantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
New method of ENBD placement (ON method)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) Patients scheduled for ENBD placement
(ii) Patients who are able to obtain written consent for research participation of their own will
(iii) Patients who are between 20 and 90 years of age at the time of consent
Key exclusion criteria
(i) Women who are pregnant or have the possibility of pregnancy
(ii) Patients who are expected to have difficulty inserting a nasal endoscope
(iii) Patients who are expected to have difficulty with ENBD placement due to previous surgeries in the nasal cavity or pharynx, etc.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Gastrointenterology and Hepatology
Zip code
413-0012
Address
13-1 Higashi-kaigan-cho Atami-City Shizuoka Japan
TEL
+81557819171
yasakamo@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Gastrointenterology and Hepatology
Zip code
413-0012
Address
13-1 Higashi-kaigan-cho Atami-City Shizuoka Japan
TEL
+81-557-81-9171
Homepage URL
yasakamo@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare Atami Hospital
Address
13-1 Higashi-kaigan-cho Atami-City Shizuoka Japan
Tel
+81557819171
yasakamo@iuhw.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
| 2022 | Year | 12 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056824
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
