UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035728 |
|---|---|
| Receipt number | R000040699 |
| Scientific Title | Retrospective Study on the Treatment Technique Using EUS-HGS for Postoperative Jejuno-biliary Anastomotic Stenosis |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/08/02 15:40:20 |
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Basic information
Public title
Retrospective Study on the Treatment Technique Using EUS-HGS for Postoperative Jejuno-biliary Anastomotic Stenosis
Acronym
Retrospective Study of EUS-HGS for Postoperative Jejuno-biliary Anastomotic Stenosis
Scientific Title
Retrospective Study on the Treatment Technique Using EUS-HGS for Postoperative Jejuno-biliary Anastomotic Stenosis
Scientific Title:Acronym
Retrospective Study of EUS-HGS for Postoperative Jejuno-biliary Anastomotic Stenosis
Region
| Japan |
Condition
Condition
postoperative jejuno-biliary anastomotic stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical outcome of EUS-HGS combined with EUS-AS for patients with postoperative jejuno-biliary anastomotic stenosis, to verify its safety and effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure success rate of EUS-AS.
Key secondary outcomes
Type, frequency of adverse event.
Indwelling period and removal success rate of metal stent detained as EUS-AS
Stenosis improvement rate under X-ray fluoroscopy
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
HUS-HGA combined with EUS-AS
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
Case in which EUS-HGS was performed in conjunction with antegrade stenting for postoperative jejuno-biliary anastomotic stenosis
Key exclusion criteria
Cases that primary endopoint information could not be obtained
Target sample size
30
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
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
+81726831221
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
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 | 31 | 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=R000040699
