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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013883
Receipt No. R000015550
Scientific Title A prospective randomized trial comparing endoscopic stent placement with surgical gastrojejunostomy in gastric outlet obstruction caused by advanced gastric cancer
Date of disclosure of the study information 2014/05/03
Last modified on 2015/12/04

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Basic information
Public title A prospective randomized trial comparing endoscopic stent placement with surgical gastrojejunostomy in gastric outlet obstruction caused by advanced gastric cancer
Acronym Surgical bypass vs endoscopic stent in malignant gastric outlet obstruction:a randomized trial
Scientific Title A prospective randomized trial comparing endoscopic stent placement with surgical gastrojejunostomy in gastric outlet obstruction caused by advanced gastric cancer
Scientific Title:Acronym Surgical bypass vs endoscopic stent in malignant gastric outlet obstruction:a randomized trial
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate non-inferiority of endoscopic stent to surgical bypass in improving oral intake in gastric outlet obstruction caused by advanced gastric cancer.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Length of the period which oral intake is possible after the intervention
Key secondary outcomes Safety of the procedure,
Improvement of oral intake,
Survival period after the procedure,
Necessity of additional intervention,
Length of the period which patient is able to stay home,
Quality of life after the procedure

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 gastrojejunal bypass
Interventions/Control_2 endoscopic stent
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Gastric adenocarcinoma diagnosed by biopsy

Un resectable cancer

Gastric cancer which does not occur in residual stomach after surgery

Patients who are not be able to take solid meal due to a stricture caused by tumor

Patients who are assessed to be able to have the operations

Blood test which is taken within 2 weeks before registration show following results;
White blood cell count >3000/mm3
Hemoglobin level >7.0 g/dL
Platelet count>100,000 /mm3
Serum total bilirubin level<3.0 mg/dL
Serum creatinine level <2.0 mg/dL

Performance status score 0-2

Patents with survival expectancy more than 3 months

The enrollment in the study is confirmed in written consent
Key exclusion criteria Cases of emergency operation for gastric perforation,bleeding or etc.

Cases of simultaneous or recurrence of heterochronous active double cancer

Patients with a history of or are suspected of brain metastasis or carcinomatous meningitis

Patients with Disseminated Intravascular Coagulation

Patients with mental disorder or abnormal mental status and are assessed to be difficult to join the study

Patients with severe ascites

Patients with a history of radiotherapy
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichirou Doki
Organization Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2,Yamadaoka,Suita,Osaka
TEL +81668793251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Takiguchi
Organization Osaka University
Division name Gastroenterological Sugery
Zip code
Address 2-2,Yamadaoka,Suita,Osaka
TEL +81668793251
Homepage URL
Email stakiguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine,Department of Gastroenterology
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine,Department of Gastroenterology
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 市立豊中病院(大阪府)、箕面市立病院(大阪府)、吹田市立病院(大阪府)、済生会千里病院(大阪府)、公立学校共済組合近畿中央病院(大阪府)、関西労災病院(兵庫県)、市立伊丹病院(兵庫県)、県立西宮病院(兵庫県)、大阪府立成人病センター(大阪府)、国立病院機構大阪医療センター(大阪府)、NTT西日本病院(大阪府)、市立堺病院(大阪府)、八尾市立病院(大阪府)、西宮市立中央病院(兵庫県)、市立池田病院(大阪府)、近大奈良病院(奈良県)、大阪船員保険病院(大阪府)、阪南中央病院(大阪府)、ベルランド病院(大阪府)、多根総合病院(大阪府)、国立病院機構呉医療センター(広島県)、大阪府立急性期総合医療センター(大阪府)、大阪府立呼吸器・アレルギー医療センター(大阪府)、市立芦屋病院(兵庫県)、りんくう総合医療センター(大阪府)、市立泉佐野病院(大阪府)、東大阪市立総合病院(大阪府)、大阪警察病院(大阪府)、大阪厚生年金病院(大阪府)、社会保険紀南病院(和歌山県)、大阪中央病院(大阪府)、大阪労災病院(大阪府)、大手前病院(大阪府)、川崎病院(大阪府)、富田林病院(大阪府)、日生病院(大阪府)、清恵会病院(大阪府)、桜橋渡辺病院(大阪府)、ガラシア病院(大阪府)、東宝塚さとう病院(兵庫県)、大阪大学消化器外科(大阪府) 

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 03 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 01 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 13 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 05 Month 03 Day
Last modified on
2015 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015550

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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