UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048423 |
|---|---|
| Receipt number | R000055184 |
| Scientific Title | A prospective study evaluating the feasibility and safety of EUS-guided biliary drainage using a modified repositionable plastic stent |
| Date of disclosure of the study information | 2022/07/21 |
| Last modified on | 2022/07/21 16:07:09 |
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Basic information
Public title
A prospective study evaluating the feasibility and safety of EUS-guided biliary drainage using a modified repositionable plastic stent
Acronym
A prospective study of EUS-guided biliary drainage using a modified repositionable plastic stent
Scientific Title
A prospective study evaluating the feasibility and safety of EUS-guided biliary drainage using a modified repositionable plastic stent
Scientific Title:Acronym
A prospective study of EUS-guided biliary drainage using a modified repositionable plastic stent
Region
| Japan |
Condition
Condition
Cases requiring biliary drainage due to biliary disease (including benign and malignant disease)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of EUS-guided biliary drainage using a modified repositionable plastic stent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate of EUS-HGS procedure (success rate for placement of modified repositionable plastic stent)
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
| Device,equipment |
Interventions/Control_1
EUS-guided biliary drainage
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. Cases in whom biliary drainage are required due to obstructive jaundice and/or cholangitis.
2. Cases in which biliary drainage by ERCP has failed due to surgical altered anatomy or duodenal stricture and in which EUS-guided biliary drainage is indicated
Key exclusion criteria
1.Cases with anatomical difficulty performing bile duct puncture under EUS
2.Cases with coagulopathy or taking antithrombotic agents that cannot be discontinue
3.Cases with sever complication in other organs
4.Cases without informed consent
5.Cases with age less than 20 years
6.Cases with pregnancy or suspect of pregnancy
7.Cases judged by principal investigator to be inadequate as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shuntaro |
| Middle name | |
| Last name | Mukai |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
s-mukai@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Shuntaro |
| Middle name | |
| Last name | Mukai |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
s-mukai@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Medical University Medical Ethics Review Board
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
IRB@tokyo-med.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 | 07 | Month | 21 | 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
| 2022 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055184
