UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049625 |
|---|---|
| Receipt number | R000056511 |
| Scientific Title | Safety and efficacy of omitting the dilation procedure in endoscopic ultrasound-guided gallbladder drainage |
| Date of disclosure of the study information | 2022/12/10 |
| Last modified on | 2024/04/14 22:11:10 |
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Basic information
Public title
Safety and efficacy of omitting the dilation procedure in endoscopic ultrasound-guided gallbladder drainage
Acronym
Safety and efficacy of omitting the dilation procedure in endoscopic ultrasound-guided gallbladder drainage
Scientific Title
Safety and efficacy of omitting the dilation procedure in endoscopic ultrasound-guided gallbladder drainage
Scientific Title:Acronym
Safety and efficacy of omitting the dilation procedure in endoscopic ultrasound-guided gallbladder drainage
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and usefulness of EUS-GBD omitting the dilation procedure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of technical success which is defined as a breakthrough of the stent sheath without dilation of the fistula.
Key secondary outcomes
Complication rate
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acute cholecystitis who were diagnosed surgically high-risk and underwent EUS-GBD
Key exclusion criteria
Massive ascites
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Ono |
Organization
Steel Memorial Muroran Hospital
Division name
Department of Pancreatobiliary Medicine
Zip code
050-0076
Address
1-45, Chiribetsucho, Muroran city, Hokkaido
TEL
0143-44-4650
onomichihiroono34@gmail.com
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Ono |
Organization
Steel Memorial Muroran Hospital
Division name
Department of Pancreatobiliary Medicine
Zip code
050-0076
Address
1-45, Chiribetsucho, Muroran city, Hokkaido
TEL
0143-44-4650
Homepage URL
onomichihiroono34@gmail.com
Sponsor or person
Institute
Steel Memorial Muroran Hospital
Institute
Department
Personal name
Funding Source
Organization
Steel Memorial Muroran 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
Steel Memorial Muroran Hospital
Address
1-45, Chiribetsucho, Muroran city, Hokkaido
Tel
0143-44-4650
onomichihiroono34@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
| 2022 | Year | 12 | Month | 10 | 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
71
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
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 10 | 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
A 19G needle for EUS-guided puncture is inserted into the endoscope's working channel to puncture the gallbladder. Contrast is injected, and a 0.035-inch stiff guidewire is inserted. Generally, this is followed by a dilation procedure, which is omitted in this study. A 12mm fully covered SEMS is introduced into the gallbladder over the guidewire without dilation.
Management information
Registered date
| 2022 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056511
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/01/13 | EUS-GBD研究計画書ｖ1.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/01/13 | 情報公開文書ｖ1.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/01/13 | EUS-GBD data for UMIN.xlsx |
