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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035728
Receipt No. 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

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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
Email 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
Email onchannopasocon@yahoo.co.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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