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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004343
Receipt No. R000004734
Scientific Title Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer
Date of disclosure of the study information 2010/10/07
Last modified on 2013/10/16

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Basic information
Public title Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer
Acronym Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer
Scientific Title Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer
Scientific Title:Acronym Randomized controlled trial comparing antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare antecolic and retrocolic Roux-en Y gastric bypass after gastrectomy for gastric cancer and to prove the non-inferiority of the antecolic route.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gastric emptying after the operation
Key secondary outcomes Nutrient state
Complication of the operation
Quality of life after the operation
Operation time
Blood loss during the operation
Endoscopic remark

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 from 2009/10/2 to 2012/9/30
The number of object is 30 per year
Patients were distributed to antecolic group and retrocolic group using a table of random numbers.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with gastric cancer
POHOCY0
Curability A or B
ECOG PS 0 or 1
No past history of surgery of the upper abdomen, and no past history of operation with int
Key exclusion criteria When non curative factor is found.
When we judged that we cannot continue the operation because of unexpected complications.
When the patient wished to discontinue.
When the operator decided to discontinue the operation.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Yamasawa
Organization National center for global health and medicine
Division name Department of eneral surgery
Zip code
Address 1-21-1 Toyama Shinjuku-ku,Tokyo
TEL 03-3202-7181
Email qpsaho@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Yamasawa
Organization National center for global health and medicine
Division name Department of general surgery
Zip code
Address 1-21-1 Toyama Shinjuku-ku,Tokyo
TEL 03-3202-7181
Homepage URL
Email qpsaho@yahoo.co.jp

Sponsor
Institute Department of gerenral surgery,National center for global health and medicine
Institute
Department

Funding Source
Organization National center for global health and medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 07 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 10 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
2010 Year 10 Month 06 Day
Last modified on
2013 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004734

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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