UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004343 |
|---|---|
| Receipt number | 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 | 2023/08/31 19:36:46 |
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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
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
qpsaho@yahoo.co.jp
Sponsor or person
Institute
Department of gerenral surgery,National center for global health and medicine
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2009 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004734
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
