UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040510 |
|---|---|
| Receipt number | R000046124 |
| Scientific Title | Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study |
| Date of disclosure of the study information | 2020/05/25 |
| Last modified on | 2021/11/25 10:45:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective study to assess the efficacy and safety of endoscopic ultrasound-guided gallbladder drainage using a metal stent with larger diameter head
Acronym
A prospective study to assess the efficacy and safety of EUS-GBD using a metal stent with larger diameter head
Scientific Title
Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study
Scientific Title:Acronym
Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the efficacy and safety of EUS-GBD using a metal stent with larger diameter head
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy (Technical success rate, Functional success rate, migration rate)
Key secondary outcomes
Safety (Adverse events 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient with acute cholecystitis who is planned for EUS-GBD
2) Age >20
3) Written informed consent
Key exclusion criteria
1) PS 4
2) Patients who cannot stop antithrombotic drugs
3) Pregnant woman
4) Platelet < 50000/uL
5) PT-INR > 1.5
6) Inappropriate patient
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Ishiwatari |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
ishihiro481019@gmail.com
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Ishiwatari |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
ishihiro481019@gmail.com
Sponsor or person
Institute
Division of Endoscopy, Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
No 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
Shizuoka Cancer Center
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
Tel
055-989-5222
ishihiro481019@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
静岡がんセンター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
5
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
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the prospective study, we will evaluate the technical/ functional success rate and stent migration rate. Stent migration is defined as completely or partially migrated stent into the gall bladder or the gastrointestinal tract. We will evaluate adverse events including stent migration through scheduled follow-up until patient death or 1 year after stent placement.
Management information
Registered date
| 2020 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046124
