UMIN-CTR Clinical Trial

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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