UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035724 |
|---|---|
| Receipt number | R000040677 |
| Scientific Title | Prospective study of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting using novel metal stent |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2019/08/02 15:35:08 |
* 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
Prospective study of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting using novel metal stent
Acronym
Prospective study of endoscopic ultrasound-guided hepaticogastrostomy with antegrade stenting using novel stent
Scientific Title
Prospective study of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting using novel metal stent
Scientific Title:Acronym
Prospective study of endoscopic ultrasound-guided hepaticogastrostomy with antegrade stenting using novel stent
Region
| Japan |
Condition
Condition
Obstructive Jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the EUS-HGAS procedure success rate for unresectable malignant biliary obstructive cases using novel metal stent
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
EUS-HGAS procedure success rate
Key secondary outcomes
Type, frequency of adverse events.
3 months after EUS - HGAS stent patency.
Clinical efficacy rate.
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
EUS-HGS with EUS-AS using novet metal stent(Zilver type 2)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
nonresectable advanced malignant tumor case
Cases requiring biliary duct drainage due to malignant bile duct obstruction
Difficult cases of biliary drainage via Vater papilla approach
Cases in which survival is expected for more than 3 months
Key exclusion criteria
Difficult cases of endoscopic approach
Perfomance status 4 case
Cases with serious complications in other organs
Informed consent case not available
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Medical College Hospital
Division name
Gastrointestinal Division
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
+81726831221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Ueno |
Organization
Osaka Medical College Hospital
Division name
Gastrointestinal Division
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
+81726831221
Homepage URL
onchannopasocon@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College
Address
2-7 Daigakumachi, Takatsuki, Osaka
Tel
0726-83-1221
rinri@osaka-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
大阪医科大学付属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 31 | 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
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 30 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040677
