UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053929 |
|---|---|
| Receipt number | R000061556 |
| Scientific Title | Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/21 15:00:52 |
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Basic information
Public title
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Acronym
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Scientific Title
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Scientific Title:Acronym
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Region
| Japan |
Condition
Condition
Biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate technical feasibility and safety of one-step deployment during EUS-HGS using novel stent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate
Key secondary outcomes
Final technical success rate, clinical success rate, adverse events, procedure time, additional rate of tract dilation, rate of bile leakage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS-HGS is performed using a partially covered self-expandable metal stent with fine gauge stent delivery system
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Biliary obstruction cases
2. Age is over 18 yo
3. Obtaining informed consent
Key exclusion criteria
1. total gastorectomy
2. ascites
3. pregnancy, risk of bleeding
4. denied to participate this study
5. Inadequate reasons which are considered by doctors
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobu |
| Middle name | |
| Last name | Nishioka |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
Homepage URL
yumegiwa8916@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Research Ethics Committee of Osaka Medical and Pharmaceutical University
Address
2-7 Daigakuchou, Takatsukishi, Osaka
Tel
072-683-1221
rinri@ompu.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
| 2024 | Year | 04 | 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
| 2024 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061556
