UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013839
Receipt number 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 22:39:43

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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 or person

Institute

Department of Gastroenterology and Hepatology, Tokyo Medical University

Institute

Department

Personal name



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

Value
https://center6.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