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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013839
Receipt No. R000016150
Scientific Title Feasibility and efficacy of novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent
Date of disclosure of the study information 2014/04/28
Last modified on 2014/04/28

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Basic information
Public title Feasibility and efficacy of novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent
Acronym Efficacy of EUS-GJ
Scientific Title Feasibility and efficacy of novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent
Scientific Title:Acronym Efficacy of EUS-GJ
Region
Japan

Condition
Condition Benign gastric outlet obstruction
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 success rate
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate
Key secondary outcomes Frequency and kinds of complications and stent patency

Base
Study type

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 Maneuver
Interventions/Control_1 EUS-guided gastrojejunostomy using Hot AXIOS stent(Xlumena)
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) Patients in whom duodenal stenosis is present and surgical gastric jejunostomy or endoscoic duodenal stenting is required. Duodenal stenosis due to benign gastric outlet obstruction.
2) Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria 1) Cases having difficulty in endoscopic approach
2) Cases difficult for EUS-FNA
3) Cases in Perfomance status 4
4) Cases with massive ascites
5) Cases with sever complication in other organs
6) Cases without informed consent
7) Cases judged by principal investigator to be inadequate as subjects
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 6-7-1 Nishishijuku, Shinjuku-ku, Tokyo 160-0023
TEL 03-3342-6111
Email itoi@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 6-7-1 Nishishijuku, Shinjuku-ku, Tokyo 160-0023
TEL 03-3342-6111
Homepage URL
Email itoi@tokyo-med.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Tokyo Medical University
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Tokyo Medical 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
Address
Tel
Email

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 東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 28 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
2014 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 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
2014 Year 04 Month 28 Day
Last modified on
2014 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016150

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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